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OpenTrials
Completed

NCT Number: NCT01814072

Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 and 60 years old
  • BMI 25-40 kg/m2
  • Weight stable (no loss or gain >25 lbs for the past 6 months)
  • Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
  • Own a Smartphone and be willing to install the Opt-IN app
  • Able to use the app to record dietary intake and weight onto the Smartphone

"Buddy" participants must:

  • 18 years of age or older
  • Have access to a computer and internet
  • Be willing to undergo "Buddy Training" and participate in 4 webinars
  • Be willing to provide support and encouragement to the participant

Exclusion criteria

  • Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
  • History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
  • Use an assistive device for mobility (e.g., wheelchair, walker, cane)
  • Plantar fasciitis
  • Hospitalization for a psychiatric disorder within the past 5 years
  • At risk for adverse cardiovascular (CVD) events with moderate intensity activity
  • Cannot read the study questionnaires
  • Committed to following an incompatible dietary regimen
  • Not be pregnant, trying to get pregnant, or lactating
  • Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
  • Low motivation to change
  • Cannot live with a current or past Opt-IN participant

Treatment and study plan

12 Telephone Coaching Sessions

Behavioral

Participants will receive 12 telephone coaching sessions

24 Telephone Coaching Sessions

Behavioral

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physician

Behavioral

Participants will have a report detailing their weight loss progress sent to their primary care physician

Text Messages

Behavioral

Participants will receive regular text messages

Recommendations to use meal replacements

Behavioral

Participants will receive recommendations from their coach to use meal replacements

Buddy Training

Behavioral

Participants will have a buddy that will be trained via webinars to be a supportive buddy

Primary outcomes

  1. Weight Change (kg) From Baseline to Month 6, Main Effect of Time

    Time frame: From Baseline to Month 6

    Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

  2. Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction

    Time frame: From Baseline to Month 6

    Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

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

Secondary outcomes

  1. Intervention for <$500

    Time frame: 6 months

    Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.

Other outcomes

  1. Treatment Adherence

    Time frame: 6 months

    Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)

  2. Self-monitoring Adherence

    Time frame: 6 months

    Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity

  3. Self-efficacy

    Time frame: 6 months

    Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity

  4. Self-Regulation

    Time frame: 6 months

    Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire

  5. Supportive Accountability

    Time frame: 6 months

    Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support

  6. Facilitation

    Time frame: 6 months

    Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Penn State University

Registry information

Acronym: Opt-IN

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2013
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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