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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Miriam Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Online Behavioral Obesity Treatment

    Behavioral

    The online behavioral obesity treatment consists of: (a) 12 weekly multimedia lessons followed by 3 monthly lessons focused on behavioral skills for weight loss and weight loss maintenance; (b) online tools for goal setting, self-monitoring of diet, physical activity, and body weight; and (c) weekly feedback messages summarizing progress toward goals and providing support and problem-solving. Participants are given recommendations to help them set goals based on their self-monitoring condition (i.e., calorie goal, lapse goal, weight loss goal) and are guided to follow a healthy eating plan to achieve weight loss and health improvement. The physical activity goal is based on baseline activity level, with gradual progression from 50 minutes per week to 250 minutes per week of moderate-intensity activity (e.g., brisk walking). The program emphasizes evidence-based behavioral strategies including stimulus control, problem-solving, goal setting, and relapse prevention.

  • Full Dietary Self-monitoring

    Behavioral

    Recording all food and drink consumed, with calorie estimates, every day.

  • Reduced-frequency Dietary Self-monitoring

    Behavioral

    Recording all food and drink consumed, with calorie estimates, on 3 days per week.

  • Self-Monitoring of Dietary Lapses Only

    Behavioral

    Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.

  • Smartwatch-based Self-monitoring of Energy Intake

    Behavioral

    Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.

  • Self-monitoring of Body Weight Only

    Behavioral

    Weighing daily using a smart scale that automatically syncs data to the online treatment platform.

Treatment groups

275 Participants
are divided into 5 treatment groups
Group A: Online Behavioral Obesity Treatment with Full Dietary Self-monitoringExperimental treatment 2 interventions
Group B: Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoringExperimental treatment 2 interventions
Group C: Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses OnlyExperimental treatment 2 interventions
Group D: Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy IntakeExperimental treatment 2 interventions
Group E: Online Behavioral Obesity Treatment with Self-monitoring of Body Weight OnlyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adherence to Self-Monitoring

Number of days on which the assigned self-monitoring strategy was used

Time frame
24 weeks
2

Weight Change

Weight measured in kg on the provided home scale

Time frame
24 weeks

Secondary outcomes

1

Perceived Burden of Assigned Self-Monitoring Approach

Self-reported perceived burden of the self-monitoring approach used during the prior 2 weeks, assessed with items adapted from the User Burden Scale (e.g., "Using this self-monitoring method required too much mental effort"). Higher scores indicate greater perceived burden.

Time frame
24 weeks
2

Motivation to Engage in Self-Monitoring

Self-reported motivation to adhere to the assigned SM approach, measured using adapted items from the Motivation for Weight Loss Scale (e.g., "I intend to self-monitor using the assigned strategy on most days over the next two weeks").

Time frame
24 weeks
3

Satisfaction With Assigned Self-Monitoring Approach

Self-reported satisfaction with the assigned SM strategy, assessed using items adapted from the Diabetes Treatment Satisfaction Questionnaire (e.g., "How satisfied were you with this self-monitoring strategy?").

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Miriam Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator