BestFIT: a Personalized Weight Loss Program

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.

Conditions

• Obesity

Interventions

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.

BEHAVIORAL

Portion-controlled meals

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.

BEHAVIORAL

Acceptance-based treatment

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.

Sponsors & Collaborators

• Drexel University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Washington

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• HealthPartners Institute

  lead OTHER

Principal Investigators

• Nancy E Sherwood, PhD · University of Minnesota

• A. Lauren Crain, PhD · HealthPartners Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2019-04-30

Completion

2019-06-30

Countries

• United States

Study Locations