NCT00606840

Brief Summary

The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

January 22, 2008

Last Update Submit

April 12, 2012

Conditions

Keywords

overweightprevention of weight gainyoung adultsself-regulationdaily weighingweight gain prevention

Outcome Measures

Primary Outcomes (1)

  • weight change

    8 weeks and 16 weeks

Secondary Outcomes (1)

  • frequency of weighing, adherence to intervention, diet, activity

    8 weeks and 16 weeks

Study Arms (2)

1

EXPERIMENTAL

One arm is a large changes group in which participants will be asked to make periodic large changes in their eating and activity, aimed at producing initial weight loss, in order to prevent weight gain over time.

Behavioral: large changes in eating and activity

2

EXPERIMENTAL

The second arm is a small changes group in which participants will be asked to make small changes to their eating and activity and maintain these changes forever in order to prevent weight gain.

Behavioral: small changes in eating and activity

Interventions

Behavioral self-regulation interventions to prevent weight gain in young adults.

1

Behavioral self-regulation interventions to prevent weight gain in young adults.

2

Eligibility Criteria

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

You may qualify if:

  • Age 18-35
  • Body mass index between 23 and 30
  • Interested in preventing weight gain

You may not qualify if:

  • BMI outside of range specified
  • Age outside of range specified
  • History of or current eating disorder or substance abuse
  • Recent weight loss greater than 5% of weight
  • Currently in another research study that would interfere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Weight GainOverweightSelf-Control

Interventions

EatingExercise

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rena R Wing, Ph.D.

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations