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BestFIT: a Personalized Weight Loss Program

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ClinicalTrials.gov Identifier: NCT02368002
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Drexel University
University of Michigan
University of Minnesota
University of Washington
National Cancer Institute (NCI)
Information provided by (Responsible Party):
HealthPartners Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Behavioral weight loss therapy Behavioral: Meal replacements Behavioral: Enhanced behavioral weight loss therapy Not Applicable

Detailed Description:
The US Preventive Services Task Force recommends referral to behavioral weight loss programs to help obese adults achieve a clinically meaningful weight loss of 8-10% of starting body weight. However, approximately half of participants are unable to achieve this goal. Despite this, a"one size fits all" approach is the norm, a major drawback because those who do not respond can in fact be detected early. This gap in weight loss intervention science calls for an adaptive intervention approach that could provide the "right treatment at the right time for the right person". Adaptive interventions individualize treatment through empirically-supported decision rules advising when and how treatments should unfold over time to maximize effectiveness. Sequential Multiple Assignment Randomized Trials (SMART), developed explicitly to build the best adaptive interventions, use experimental design principles to develop these decision rules. The investigators will use a SMART to systematically evaluate therapeutic approach and timing differences for intervening with those who do not respond to a behavioral weight loss program. Self-regulation challenges have been identified as a major adherence barrier. Two attractive options to address self-regulation difficulties are: 1) supplementing behavioral treatment with Meal Replacements (MR) which decreases the need for self-regulation; and 2) switching therapeutic approaches by using an enhanced version of behavioral weight loss therapy that teaches acceptance based behavioral skills which boost capacity for self-regulation. Additionally, two time points for intervening with non-responders will be evaluated: 1) 3 weeks, based on current weight loss trial evidence; and 2) 7 weeks, based on average time used in the existing stepped care literature. Adults (n=500) will be recruited and will receive individual behavioral weight loss treatment (BWL). Participants will be randomized to either: 1) treatment response assessment at 3 weeks or 2) treatment response assessment at 7 weeks. Subjects who have lost the expected amount of weight at their assessment point, will continue with traditional behavioral weight loss therapy. For those who have not lost the expected amount of weight, we will re-randomize them to either meal replacements in addition to the traditional weight loss therapy or to the enhanced version of behavioral weight loss therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 469 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 21 - 70
  • BMI between 30 - 45 kg/m2
  • Able to walk 2 blocks without stopping
  • Able to attend measurement and intervention activities in the Twin Cities area in person for 18 months

Exclusion Criteria:

  • Self-reported pregnancy or breastfeeding baby in last 6 months or planning a pregnancy in the next 18 months
  • History of bariatric surgery
  • Current or previous diagnosis of anorexia nervosa or bulimia nervosa
  • Food allergies, intolerances

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
HealthPartners Institute
Bloomington, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute
Drexel University
University of Michigan
University of Minnesota
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nancy E Sherwood, PhD University of Minnesota
Principal Investigator: A. Lauren Crain, PhD HealthPartners Institute

Publications:

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02368002     History of Changes
Other Study ID Numbers: 1R01CA188892-01 ( U.S. NIH Grant/Contract )
1R01CA188892-01 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Keywords provided by HealthPartners Institute:
obesity
diet, reducing
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes