NCT00488228

Brief Summary

The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2007

Shorter than P25 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

Study Start

First participant enrolled

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 13, 2012

Status Verified

January 1, 2008

Enrollment Period

7 months

First QC Date

June 18, 2007

Last Update Submit

April 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight change

    10 weeks and 20 weeks

Secondary Outcomes (1)

  • eating disorder symptoms, physical activity, body image, mood symptoms, and self-efficacy about eating behavior

    10 weeks and 20 weeks

Study Arms (2)

1

EXPERIMENTAL

Participants in the behavioral self-regulation intervention will receive a modified standard treatment that incorporates daily weighing and training in self-regulation methods for weight loss. All treatment modules are adapted for a young adult age group.

Behavioral: self-regulation

2

EXPERIMENTAL

Participants in the Standard group will receive a brief version of standard behavioral weight loss treatment with treatment modules tailored to better meet the needs of young adults.

Behavioral: self-regulation

Interventions

self-regulationBEHAVIORAL

The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.

12

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index between 27 and 40
  • age between 21 and 35

You may not qualify if:

  • report a history of eating disorder or a current eating disorder
  • report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
  • report major psychiatric diseases or organic brain syndromes
  • currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
  • pregnant, lactating, or less than 6 months post-partum
  • intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Gokee-Larose J, Gorin AA, Wing RR. Behavioral self-regulation for weight loss in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2009 Feb 16;6:10. doi: 10.1186/1479-5868-6-10.

MeSH Terms

Conditions

Obesity

Interventions

Professional Autonomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Jessica G LaRose, Ph.D.

    The Miriam Hospital

    STUDY DIRECTOR
  • Rena R Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 13, 2012

Record last verified: 2008-01

Locations