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

Recruiting · NCT07228130 · Interventional (participants receive a specific treatment) · Lead sponsor: The Miriam Hospital

View the official record on ClinicalTrials.gov →

Obesity

Interventions studied

Full Dietary Self-monitoringOnline Behavioral Obesity TreatmentReduced-frequency Dietary Self-monitoringSelf-Monitoring of Dietary Lapses OnlySelf-monitoring of Body Weight OnlySmartwatch-based Self-monitoring of Energy Intake

What this trial is about

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.

Who can take part

Age range

18 Years to 70 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

* 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

Where it is running

1 location listed across 1 US state.

The Weight Control and Diabetes Research Center of The Miriam Hospital & Brown University - Providence, Rhode Island, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →