BestFIT: a Personalized Weight Loss Program
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02368002|
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : July 23, 2019
The purpose of this study is to learn how to personalize weight loss programs. In this research we will study:
- 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
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Behavioral weight loss therapy Behavioral: Meal replacements Behavioral: Enhanced behavioral weight loss therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||469 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||June 2019|
Experimental: Behavioral weight loss therapy
Emphasizes 1) identifying behaviors in need of change, 2) setting goals for change, 3) monitoring progress, 4) modifying environmental cues to facilitate change, and 5) modifying consequences to motivate change.
Behavioral: Behavioral weight loss therapy
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.
Experimental: Meal replacements
Fifty percent of participants who have not lost the expected amount of weight will be re-randomized to receive meal replacements in addition to standard behavioral weight loss therapy.
Behavioral: Meal replacements
Participants continue with behavioral weight loss therapy, but this is augmented with meal replacements (MR). Adherence to energy intake goals is facilitated by consuming pre-prepared meals specifically designed to meet caloric intake guidelines. MRs reduce individuals' motivationally- and self-regulatory-dependent planning and decision making around eating. MRs also serve as a "teaching tool" regarding the amount and type of food people should eat in order to produce weight loss.
Experimental: Enhanced behavioral weight loss therapy
Fifty percent of participants who have not lost the expected amount of weight will be re-randomized to receive an enhanced version of behavioral weight loss therapy.
Behavioral: Enhanced behavioral weight loss therapy
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.
- Change from baseline in weight for those receiving meal replacements versus enhanced weight loss therapy [ Time Frame: 6 months and 18 months after baseline ]To evaluate, among non-responders to behavioral weight loss therapy, the benefit of augmenting initial treatment with Meal Replacements versus switching to Enhanced behavioral weight loss therapy.
- Change from baseline in weight for those receiving weight loss assessment after 3 weekly sessions versus 7 weekly sessions [ Time Frame: 6 and 18 months after baseline ]To evaluate the optimal timing for identifying non-responders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368002
|United States, Minnesota|
|Bloomington, Minnesota, United States, 55425|
|Principal Investigator:||Nancy E Sherwood, PhD||University of Minnesota|
|Principal Investigator:||A. Lauren Crain, PhD||HealthPartners Institute|