Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Overweight and Obesity

Being tested

Online Behavioral Weight Loss Program, Virtual Reality for Behavioral Weight Loss Skills Training, Tailored Interactive Video Feedback, Tailored Intervention for Structured Physical Activity, Skills Training for Dysregulated Eating

Keywords

Diet, Physical activity, Online

Medical subject headings

Overweight, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Online Behavioral Weight Loss ProgramBehavioural

  A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.

• Virtual Reality for Behavioral Weight Loss Skills TrainingBehavioural

  This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.

• Tailored Interactive Video FeedbackBehavioural

  Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity. Additional videos provide dietary skills training.

• Tailored Intervention for Structured Physical ActivityBehavioural

  Periodic self-assessment is used to guide selection of a physical activity goal. Home-based instructional videos are provided to help meet the selected goal.

• Skills Training for Dysregulated EatingBehavioural

  Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).

• Platform for Social Support & Friendly CompetitionBehavioural

  An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Main Effect of Time

   Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight).

   A change between two time points is reported. The value of this outcome was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all randomized participants were included in the model (ITT analysis).

   Measured: From Baseline to Month 12

2. Weight Change (Percent of Initial Body Weight) From Baseline to Month 12, Time by Intervention Component Interaction

   Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight).

   A change between two time points is reported. The value of this outcome was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100. Estimated mean change was obtained from a linear mixed models analysis of variance. Data from all randomized participants were included in the model (ITT analysis).

   This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each intervention component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).

   Measured: From Baseline to Month 12

3. Proportion of Participants With Weight Loss ≥ 5% at Month 12, Main Effect of Time

   Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight).

   Weight loss was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100.

   The estimated proportion of participants achieving a weight loss of ≥ 5% of their Baseline body weight was obtained from a generalized linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

   Measured: Month 12

4. Proportion of Participants With Weight Loss ≥ 5% at Month 12, Time by Intervention Component Interaction

   Weight was measured at the research center by the research team, or measured by the participant at home and sent to the research team with with documentation of the value reported (e.g., a photograph from a home scale showing the weight).

   Weight loss was calculated using: [(baseline weight - month 12 weight) ÷ baseline weight] × 100.

   Estimated proportions of participants with weight loss of ≥ 5% of initial body weight at Month 12 were obtained from a generalized linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

   Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Aug 2020
2. Study start22 Sep 2020
3. Primary completion18 May 2023
4. Study completion18 May 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Overweight and ObesityStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.