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Weight Gain Prevention

Primary Purpose

Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
large changes in eating and activity
small changes in eating and activity
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring overweight, prevention of weight gain, young adults, self-regulation, daily weighing, weight gain prevention

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

weight change

Secondary Outcome Measures

frequency of weighing, adherence to intervention, diet, activity

Full Information

First Posted
January 22, 2008
Last Updated
April 12, 2012
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00606840
Brief Title
Weight Gain Prevention
Official Title
Study to Prevent Weight Gain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
overweight, prevention of weight gain, young adults, self-regulation, daily weighing, weight gain prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
large changes in eating and activity
Intervention Description
Behavioral self-regulation interventions to prevent weight gain in young adults.
Intervention Type
Behavioral
Intervention Name(s)
small changes in eating and activity
Intervention Description
Behavioral self-regulation interventions to prevent weight gain in young adults.
Primary Outcome Measure Information:
Title
weight change
Time Frame
8 weeks and 16 weeks
Secondary Outcome Measure Information:
Title
frequency of weighing, adherence to intervention, diet, activity
Time Frame
8 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena R Wing, Ph.D.
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Weight Gain Prevention

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