NCT02368002

Brief Summary

The purpose of this study is to learn how to personalize weight loss programs. In this research we will study:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 3, 2021

Completed
Last Updated

December 3, 2021

Status Verified

July 1, 2019

Enrollment Period

3.9 years

First QC Date

February 6, 2015

Results QC Date

June 13, 2020

Last Update Submit

December 2, 2021

Conditions

Obesity

Keywords

obesitydiet, reducing

Outcome Measures

Primary Outcomes (1)

  • Weight Change

    Weight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.

    6 months and 18 months after baseline

Secondary Outcomes (1)

  • Weight Change

    6 and 18 months after baseline

Study Arms (3)

Behavioral weight loss therapy

EXPERIMENTAL

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

Portion-controlled meals

EXPERIMENTAL

Fifty percent of participants who have not lost the expected amount of weight will be re-randomized to receive portion-controlled meals in addition to standard behavioral weight loss therapy.

Behavioral: Portion-controlled meals

Acceptance-based treatment

EXPERIMENTAL

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 teaching acceptance-based behavioral skills.

Behavioral: Acceptance-based treatment

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.

Behavioral weight loss therapy
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.

Portion-controlled meals
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.

Acceptance-based treatment

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Institute

Bloomington, Minnesota, 55425, United States

Location

Related Publications (11)

  • Carels RA, Darby L, Cacciapaglia HM, Douglass OM, Harper J, Kaplar ME, Konrad K, Rydin S, Tonkin K. Applying a stepped-care approach to the treatment of obesity. J Psychosom Res. 2005 Dec;59(6):375-83. doi: 10.1016/j.jpsychores.2005.06.060.

    PMID: 16310019BACKGROUND

  • Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A "SMART" design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. doi: 10.1146/annurev-clinpsy-032511-143152. Epub 2011 Dec 12.

    PMID: 22224838BACKGROUND

  • Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.

    PMID: 17466815BACKGROUND

  • Butryn ML, Webb V, Wadden TA. Behavioral treatment of obesity. Psychiatr Clin North Am. 2011 Dec;34(4):841-59. doi: 10.1016/j.psc.2011.08.006.

    PMID: 22098808BACKGROUND

  • Rock CL, Flatt SW, Sherwood NE, Karanja N, Pakiz B, Thomson CA. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010 Oct 27;304(16):1803-10. doi: 10.1001/jama.2010.1503. Epub 2010 Oct 9.

    PMID: 20935338BACKGROUND

  • Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.

    PMID: 12704397BACKGROUND

  • Forman EM, Hoffman KL, McGrath KB, Herbert JD, Brandsma LL, Lowe MR. A comparison of acceptance- and control-based strategies for coping with food cravings: an analog study. Behav Res Ther. 2007 Oct;45(10):2372-86. doi: 10.1016/j.brat.2007.04.004. Epub 2007 Apr 18.

    PMID: 17544361BACKGROUND

  • Sherwood NE, Butryn ML, Forman EM, Almirall D, Seburg EM, Lauren Crain A, Kunin-Batson AS, Hayes MG, Levy RL, Jeffery RW. The BestFIT trial: A SMART approach to developing individualized weight loss treatments. Contemp Clin Trials. 2016 Mar;47:209-16. doi: 10.1016/j.cct.2016.01.011. Epub 2016 Jan 26.

    PMID: 26825020BACKGROUND

  • Emery Tavernier RL, Mason SM, Levy RL, Seburg EM, Sherwood NE. Association of childhood abuse with behavioral weight-loss outcomes: Examining the mediating effect of binge eating severity. Obesity (Silver Spring). 2022 Jan;30(1):96-105. doi: 10.1002/oby.23320.

    PMID: 34932887DERIVED

  • Sherwood NE, Crain AL, Seburg EM, Butryn ML, Forman EM, Crane MM, Levy RL, Kunin-Batson AS, Jeffery RW. BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Ann Behav Med. 2022 Mar 1;56(3):291-304. doi: 10.1093/abm/kaab061.

    PMID: 34415011DERIVED

  • Crane MM, Seburg EM, Levy RL, Jeffery RW, Sherwood NE. Using targeting to recruit men and women of color into a behavioral weight loss trial. Trials. 2020 Jun 16;21(1):537. doi: 10.1186/s13063-020-04500-1.

    PMID: 32546253DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Nancy Sherwood
Organization
University of Minnesota
sherw005@umn.edu
612-625-4567

Study Officials

  • Nancy E Sherwood, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • A. Lauren Crain, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 20, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2019

Study Completion

June 1, 2019

Last Updated

December 3, 2021

Results First Posted

December 3, 2021

Record last verified: 2019-07

Locations

US(1)