CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 468 enrolled
Drug / intervention
Behavioral weight loss therapy +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02368002
NCT02368002N/ACompleted

Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss

HealthPartners Institute·interventional·Posted Feb 20, 2015·Updated Dec 3, 2021

In Brief

A clinical study evaluating Behavioral weight loss therapy, Portion-controlled meals, and 1 other intervention for Obesity. Completed, enrolled 468 participants across 1 site.

Detailed Summary

The purpose of this study is to learn how to personalize weight loss programs. In this research we will study: 1. Whether a weight loss counselor should decide if the traditional weight loss therapy is working either after 3 or 7 weekly sessions of therapy and 2. For those who haven't lost the expected amount of weight, whether it is more effective to add packaged meals to the traditional weight loss therapy or to change to an enhanced version of behavioral weight loss therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartMay 1, 2015
Primary CompletionApr 1, 2019
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.4 years ago

Interventions

Behavioral weight loss therapybehavioral

All participants start with behavioral weight loss therapy which consists of 20 weekly meetings wtih a weight loss coach. Session components will include weekly weigh-in, discussion of progress and challenges and discussion of scheduled session topic. Dietary goals and physical activity goals are set. After their first session, participants are randomized to have their weight assessed at either their 3rd session or their 7th session. Both the participant and their coach are blinded to the randomization. If the participant has lost the expected amount of weight, they continue with behavioral weight loss therapy for the full 20 session.

Portion-controlled mealsbehavioral

Participants continue with behavioral weight loss therapy, but this is augmented with portion-controlled meals (PCM). Adherence to energy intake goals is facilitated by consuming pre-prepared meals specifically designed to meet caloric intake guidelines. PCMs reduce individuals' motivationally- and self-regulatory-dependent planning and decision making around eating. PCMs also serve as a "teaching tool" regarding the amount and type of food people should eat in order to produce weight loss.

Acceptance-based treatmentbehavioral

Switching the therapeutic approach to an enhanced behavioral weight loss therapy teaching acceptance-based behavioral skills theoretically addresses the root problem of many weight loss challenges and boosts long-term capacity for self-regulation. Acceptance based strategies are designed to help participants identify and internalize values and lasting commitment to behavior consistent with these values. The strategies focus on increasing people's ability to forgo more pleasurable options (e.g., hedonic pleasure of food) in favor of behavior that is distinctly less pleasurable or even aversive (remaining hungry, anxious, bored). The inability to tolerate such distress is directly associated with failure of self-regulation.