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Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial is focused on testing dietary self-monitoring strategies used in behavioral obesity treatment. The goal is to determine which self-monitoring strategies are most useful for whom, at which points in treatment, and under what circumstances. Researchers will provide a 24-week online behavioral obesity treatment program, and will randomize participants to use one of 5 dietary self-monitoring strategies every two weeks. The five strategies include: recording all food and drink consumed and corresponding energy intake (i.e., calories) on 7 days per week; recording all food and drink consumed and corresponding energy intake (i.e., calories) on 3 days per week; self-monitoring of dietary lapses (i.e. any eating/drinking likely to cause weight gain or put weight loss at risk); smartwatch-based monitoring of energy intake (i.e., calories); and self-monitoring of body weight only via smart scale. Participants will: * Follow a 24-week online program for weight loss and health improvement * Use the assigned self-monitoring strategy every two weeks * Meet with the researchers periodically via online video call and provide research data by answering questions via periodic online surveys.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• English language fluent and literate at the 6th grade level

• Body mass index (BMI) above 25 kg/m-squared

• Able to walk 2 city blocks without stopping

• Not currently participating in another weight loss program

• Not currently taking weight loss medication

• Has not lost ≥5% of body weight in the 6 months prior to enrolling

• Has not been pregnant within the 6 months prior to enrolling

• Does not plan to become pregnant within 12 months of enrolling

• Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling

• Denies any medical condition that would affect the safety of participating in unsupervised physical activity

• Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness

• Owns a smartphone compatible with study procedures and is willing to use it for study participation

Locations
United States
Rhode Island
The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown University
RECRUITING
Providence
Contact Information
Primary
Jill Eisel Research Project Coordinator
tech2trackstudy@brownhealth.org
401-793-8283
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 275
Treatments
Experimental: Online Behavioral Obesity Treatment with Full Dietary Self-monitoring
The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention.
Experimental: Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring
The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention.
Experimental: Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only
The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention.
Experimental: Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake
The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention.
Experimental: Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only
The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: The Miriam Hospital

This content was sourced from clinicaltrials.gov