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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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Clinicaltrials.gov | Behavioral Self-Regulation | Completed | Obesity | Behavioral - self-regulation | The Miriam Hospital, Other | 18 Years - 35 Years | N/A | Interventional | The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults. | ||
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Clinicaltrials.gov | Changes in Food Reinforcement During Obesity Treatment | Completed | Obesity | Behavioral - hypocaloric, low-fat diet | The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 21 Years - 70 Years | N/A | Interventional | The reinforcing value of food, or how much a person "wants" a food, is an important determinant of food intake. Thus far, food reinforcement has only been studied in laboratory settings, and no studies have examined whether the reinforcing value of food is altered when dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat diet is implemented for weight loss may increase the reinforcing value of all foods, but particularly for restricted high-fat foods. Greater increases in the reinforcing value of high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted eating behaviors that produce weight loss, whereas greater increases in the reinforcing value of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors. The aim of this application is to measure food reinforcement in a clinical setting to determine if food reinforcement changes when a traditional weight loss diet is prescribed. For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to either a 6-month weight loss intervention or usual care. Assessments of food reinforcement, dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group changes their diet relative to the usual care group, it is hypothesized: 1) the intervention group will have greater increases in the reinforcing value of both high- and low-fat foods than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases in frequency of consumption of high-fat foods will be related to increases in the reinforcing value of high-fat foods from 0 to 6 months. These results will lead to a novel line of research, examining the relationship between food reinforcement and weight loss maintenance, so that diets can be designed to promote changes in food reinforcement that aid in sustaining dietary changes and weight loss. | |
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Clinicaltrials.gov | Liking of Snack Foods - Sub-Study 1 | Completed | Eating Behavior, Obesity, Satiation | Behavioral - portion or unportioned food | The Miriam Hospital, Other | 18 Years - 50 Years | N/A | Interventional | Specific Aims: Environmental factors contributing to overconsumption, such as larger food portion sizes, may be contributing to the obesity epidemic. The objective of the proposed study is to examine the independent and combined effects of portion size and quantity of food on intake in normal weight males and females. Participants will be randomly assigned to one of four conditions varying in the portion size and quantity of junk food provided: small quantity of food packaged in small portions (SSP), small quantity of food packaged in large portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity of food packaged in large portions (LLP). A box containing four different junk foods, packaged according to one of the four conditions, will be given to participants to take home for three days. The total amount of food consumed from the box over the three days will be measured. It is anticipated that portion size and quantity of food, both independently and combined, will influence intake, such that larger portion sizes and quantity of food provided to participants will produce greater intake.Subject Population: We propose to recruit 60 healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal to 28. Participants will be non-smokers, unrestrained eaters, and have no known food allergies to the foods used in the investigation.Methods/Design: Participants will be randomly assigned to one of four conditions, varying in portion size (small versus large) and quantity of food provided (small versus large). A box containing four junk foods, packaged according to one of the conditions, will be provided to participants. They will be encouraged to eat as much or as little of the food as they want, but to at least taste each of the four foods over the three-day period. During this time, they will be instructed to not eat any other junk foods. At the end of the three-day period, participants will return the box with any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams and kcals consumed from the provided junk foods, will be examined between the four different conditions.Significance: If portion size and quantity are related to intake, subsequent studies will develop clinical interventions related to reducing portion size and/or quantity of food available in the household. | ||
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Clinicaltrials.gov | Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity | Recruiting | Obesity | Behavioral, Behavioral, Behavioral, Behavioral - Behavioral Weight Loss Intervention, Minority Stress Intervention, Negative Body Image Intervention, Social Support Intervention | The Miriam Hospital, National Institute on Minority Health and Health Disparities (NIMHD), Other, NIH | Female | 18 Years - 70 Years | N/A | Interventional | Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined. | |
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Clinicaltrials.gov | Self-compassion and Nutrition (SCAN) Study | Completed | Obesity, Weight Loss | Behavioral, Behavioral, Behavioral - Behavioral weight loss program, Self-compassion, Nutrition and cooking education | The Miriam Hospital, Other | Female | 18 Years - 65 Years | N/A | Interventional | The purpose of this study is to examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education intervention (determined via randomization procedures). Assessments of weight, physical activity, and other weight-related and psychosocial factors will occur at baseline, 4 months, 6 months, and 9 months. | |
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Clinicaltrials.gov | Weight Watchers Online 2015 | Completed | Obesity, Overweight, Body Weight | Behavioral, Other - Weight Watchers Online 2015 Program, Electronic Scale with Feedback | The Miriam Hospital, Weight Watchers International, University of Tennessee, Other, Industry, Other | 18 Years - 70 Years | N/A | Interventional | The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program revised for 2015 (WWO2015) and WWO2015 plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015 Enhanced), over a 6-month period. | ||
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Clinicaltrials.gov | Reducing Sedentary Time in Obese Adults (Study 2) | Withdrawn | Obesity | Behavioral, Behavioral - B-MOBILE Smartphone-Based Intervention (3-min break), B-MOBILE Smartphone-Based Intervention (6-min break) | The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 21 Years - 70 Years | N/A | Interventional | Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations. | ||
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Clinicaltrials.gov | The Effects of Mindsets on the Brain's Response to Food Cues | Unknown status | Obesity | The Miriam Hospital, The Obesity Society, Other, Other | 25 Years - 55 Years | Observational | Previous studies have shown that obese individuals exhibit greater reward-related brain activity in response to food cues than lean individuals and our group has shown that successful weight loss maintainers who were previously obese and now maintain a healthy weight have increased control-related activity when viewing food cues. These findings suggest key roles for both reward-related brain areas and inhibitory control regions in eating behavior. However, no studies to date have examined (a) whether the response to food cues (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most effective at altering brain response to food cues, or (c) the neural mechanisms that support such change. Given the omnipresent environmental cues to eat and the association between heightened reward-responsivity and obesity, it is critical to investigate ways to potentially alter food cue-reactivity in the obese. The most widely employed approach for behavioral weight loss treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else). This approach is sometimes described as "change- focused" because modifying negative thoughts is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively, emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches participants to recognize and accept their cravings as feelings that need not be acted upon, may also be effective in treating obesity. A third strategy often employed in smoking cessation and substance abuse treatment is to focus on the long-term consequences of behaviors, however this form of treatment is not typically used in behavioral weight loss therapy. Thus although each approach is potentially effective, these treatment approaches differ greatly in the cognitive strategies they employ. The primary aim of the proposed research is to compare a cognitive strategy used in CBT ('CHANGE'), a cognitive strategy emphasized in ACT ('ACCEPT'), and a cognitive strategy used in smoking cessation ('LATER') relative to a control condition ('NOW'), in their effectiveness in altering reward and inhibitory control responses to food cues among obese individuals. | ||||
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Clinicaltrials.gov | Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial | Completed | Obesity | Behavioral, Behavioral, Behavioral, Behavioral - Nutrition Education, Behavioral Weight Loss Strategies, Standard Cognitive Techniques, Acceptance Based Techniques | The Miriam Hospital, Other | 18 Years - 70 Years | N/A | Interventional | The proposed project is testing two behavioral interventions designed to improve long-term weight loss among participants who struggle with eating in response to stress or emotional experiences. Group treatment lasts for 1 year, with assessments lasting 2 years. Participants must live in the greater Providence, Rhode Island area in order to be eligible. | ||
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Clinicaltrials.gov | Emotion Regulation and Binge Eating in Youth With Obesity | Completed | Obesity, Binge-Eating Disorder | The Miriam Hospital, Other | 10 Years - 17 Years | Observational | This study will investigate neural activation patterns in emotion- and cognition-related brain regions during an emotion regulation task involving cognitive reappraisal, and their associations with age and pubertal status, among overweight children and adolescents with loss of control eating as compared to overweight and normal-weight controls. | ||||
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Clinicaltrials.gov | An Internet-based Behavioral Weight Loss Program for HIV+ Patients | Completed | Overweight, Obesity, HIV | Behavioral, Behavioral - Internet Behavioral Intervention, Internet Education Intervention | The Miriam Hospital, Brown University, National Institute of Allergy and Infectious Diseases (NIAID), Other, Other, NIH | 18 Years - 70 Years | N/A | Interventional | The goal of this project is to determine whether an Internet-based weight loss program will lead to weight loss and improvements in cardiovascular disease risk factors in people living with HIV. | ||
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Clinicaltrials.gov | Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss | Unknown status | Overweight, Obesity | Behavioral, Behavioral, Behavioral - Online Behavioral Weight Loss program, Weight Loss Nomogram, Bite Counter | The Miriam Hospital, Other | 18 Years - 70 Years | N/A | Interventional | Behavioral lifestyle treatment for obesity produces clinically significant weight loss and corresponding improvements in disease risk and severity when delivered via in-person group and/or individual treatment sessions. Online versions have been developed in order to reduce costs. These programs typically include weekly weight loss lessons and tailored feedback on patients' weight loss progress. However, online programs often produce suboptimal outcomes compared to programs delivered in-person due to insufficient adherence to prescribed behavioral strategies, and a lack of objective methods for behavioral self-monitoring to support adherence. One approach to monitoring and improving adherence involves tracking patients' weight loss progress on a personalized nomogram (i.e., graph). The nomogram is based on a dynamic energy balance equation and depicts the expected weight loss over time if the participant is adherent to a prescribed goal for caloric intake and physical activity. A complementary approach to measuring and intervening on adherence involves the use of mobile technology to monitor eating behavior. The Bite Counter is a wrist-worn device similar to a wristwatch that measures the timing, frequency, rate, and duration of eating events by monitoring the "wrist roll" motion that occurs when food is brought to the mouth. By using mathematical models to "calibrate" the Bite Counter to the weight loss nomogram, it may be possible to identify the optimal number of bites that any given patient should take each day in order to facilitate weight loss. The purpose of the proposed study is to conduct a small randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of adding weight loss nomograms and the Bite Counter to an established online weight loss program. A sample of 30 participants with overweight/obesity will be randomly assigned in equal proportions to one of three 12-week weight loss programs: (a) online behavioral weight loss treatment alone (OBWL), (b) online behavioral weight loss treatment plus the provision of weight loss nomograms with weekly feedback tailored to the nomogram (OBWL+N), or (c) online behavioral weight loss treatment plus the provision of weight loss nomograms with weekly feedback tailored to the nomogram and provision of a Bite Counter that can be used to alert participants when they are approaching their maximum number of prescribed bites per day (OBWL+N&BC). | ||
Clinicaltrials.gov | Exercise as a Buffer Against Stress-induced Overeating | Completed | Obesity | Other, Other - Exercise intervention, Delayed exercise intervention | The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 18 Years - 60 Years | N/A | Interventional | The purpose of this study is to examine the psychological benefits of chronic exercise as well as the effects of exercise training on eating behaviors and stress-induced overeating in overweight and obese women. Participants will be randomized to an 12-week exercise condition or a delayed exercise condition. Assessments will occur at baseline, 6 weeks, and 12 weeks and will include answering surveys in real-time using smartphones, several assessments of eating behaviors and dietary intake, and questionnaire measures of factors which could mediate the relationship between exercise and eating. Participants will be compensated for completing assessments and for adherence to the exercise protocol. | |
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Clinicaltrials.gov | Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss | Completed | Overweight, Obesity | Behavioral, Behavioral, Behavioral - Self-monitoring skills, Technology, Interventionist Contact | The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 70 Years | N/A | Interventional | Despite continued research on effective interventions, obesity remains a major public health issue in the United States. Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight. Despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented. Two key questions need to be addressed. First, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact? Second, how cost-effective is a technology-based intervention, with and without interventionist contact? The current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to a technology only condition (TECH) and a technology plus interventionist support condition (TECH+INT). All participants will all be given basic weight management information knowledge and randomized to one of three conditions. Participants in the self-guided self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (TECH+INT) will receive the same technology as in the TECH condition, combined with weekly interventionist contact delivered via telephone. We will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness. | ||
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Clinicaltrials.gov | Modifying Obesogenic Homes: Impact on Weight Maintenance | Unknown status | Obesity | Behavioral, Behavioral - Behavioral weight loss treatment, Behavioral and home environment weight loss treatment | The Miriam Hospital, National Heart, Lung, and Blood Institute (NHLBI), Other, NIH | 21 Years - 70 Years | N/A | Interventional | The obesity epidemic observed in recent years can be largely attributed to an obesogenic environment that encourages overeating and sedentary lifestyles. Behavioral weight control treatment, the most empirically validated intervention approach, produces initial weight losses of 10%; however, maintenance of initial weight loss and behavior change has not been achieved. These disappointing long-term results may reflect the fact that participants are given only minimal, indirect instruction on how to change their environment to support their new weight-regulating behaviors. While in theory, the behavioral model emphasizes environmental antecedents and consequences of eating and exercise, in practice, only 1 to 2 sessions in standard treatment are dedicated to stimulus control-types of skills. By teaching weight control skills in a contextual vacuum, participants remain vulnerable to the same environmental influences that maintained their unhealthy eating and exercise habits. Given that the majority of eating and exercise is home-based, a logical step in strengthening behavioral treatment and moving toward an ecological model of behavior is to expand the focus of treatment from the individual to the individual plus their home environment. We propose to test the long-term impact of a behavioral weight control program designed to directly modify both the physical and social home environment of weight loss participants. Two hundred overweight and obese men and women will be randomly assigned to either 18 months of standard behavioral treatment (SBT) or 18 months of standard behavioral treatment plus direct modifications to the home environment (SBT+Home). SBT+Home will incorporate many strategies that have shown promise in improving weight loss (e.g., food and exercise equipment provision, spouse involvement) but will be the first to study both physical and social factors within the home simultaneously and will be the longest examination of the home environment conducted to date. Participants and spouses will be assessed at baseline, 6, 12, and 18 months. We hypothesize that by broadening the focus of treatment from the individual to the individual plus their home environment, SBT+Home will produce both better long-term weight loss and better maintenance of initial weight loss and behavior change. This home environmental approach, if successful, has potential applications to the maintenance of other important health behaviors. | ||
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Clinicaltrials.gov | Reducing Snack Variety in Weight Loss Treatment | Completed | Obesity | Behavioral, Behavioral - Standard, Limited Variety | The Miriam Hospital, National Institutes of Health (NIH), Other, NIH | 21 Years - 65 Years | N/A | Interventional | The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Although decreasing portion sizes is a strategy used in weight loss programs, research has not studied the effects of decreasing dietary variety. Cross-sectional studies show a positive association between variety and body weight and in our own studies the investigators have shown that greater reductions in the number of different snack foods (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake and greater weight loss. Limiting variety may reduce intake through long-term sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary approach with the potential to improve long-term weight loss, which has not been studied as a clinical strategy in obesity research. The objective of this application is to conduct a randomized controlled trial of a behavioral weight loss intervention limiting the number of different snack foods consumed. Two hundred overweight and obese participants will be randomized to a standard behavioral intervention (Standard) or to a standard behavioral intervention that also limits the number of different snack foods consumed (Limited Variety). Both conditions will receive an 18-month standard behavioral intervention, using behavioral techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited Variety condition will also limit variety in snack foods to only two chosen snack foods throughout the intervention. Measures of weight, snack food consumption and hedonics, and diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will determine: 1. if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months; 2. if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition; 3. if limiting snack food variety produces long-term sensory-specific satiety and/or monotony. Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake. To date, there is no dietary prescription that has been tested that capitalizes on the effect of variety on intake that can be maintained. This will be the first investigation to examine methods of manipulating dietary variety that can be adhered to over time and that influence intake, weight loss, and weight loss maintenance. | ||
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Clinicaltrials.gov | Weight Watchers Online | Completed | Overweight, Obesity | Behavioral, Device, Behavioral - Weight Watchers Online Program, Philips ActiveLink, Eating and Activity Newsletter | The Miriam Hospital, Weight Watchers International, University of Tennessee, Other, Industry, Other | 18 Years - 70 Years | N/A | Interventional | The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group. | ||
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Clinicaltrials.gov | Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment | Completed | Overweight, Obesity | Behavioral - Affective and Cognitive Skills Training | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Miriam Hospital, NIH, Other | 21 Years - 70 Years | N/A | Interventional | Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20 participants to initially assess acceptability and efficacy of the innovative treatment. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors. | ||
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Clinicaltrials.gov | Brief Behavioral Weight Loss Treatment vs. Weight Watchers | Completed | Obesity, Overweight | Behavioral, Behavioral, Behavioral - Weight Watchers, brief behavioral weight loss treatment, brief behavioral + Weight Watchers combined treatment | The Miriam Hospital, Other | 21 Years - 65 Years | N/A | Interventional | The purpose of this study is to compare the effectiveness of Weight Watchers, brief behavioral treatment, and a combination treatment. We hypothesize that a combination treatment will achieve greater weight losses than Weight Watchers alone. | ||
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Clinicaltrials.gov | Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors | Completed | Sleep, Obesity | Behavioral - Optimize Sleep | The Miriam Hospital, Temple University, Other, Other | 8 Years - 11 Years | N/A | Interventional | The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight. |
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