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Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard behavioral treatment for weight loss
Modified behavioral treatment for weight loss
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI between 27 and 45 kg/m2

Exclusion Criteria:

  • participating in a weight loss program or taking a weight loss medication
  • currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention.
  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).

Sites / Locations

  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.

A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.

Outcomes

Primary Outcome Measures

weight

Secondary Outcome Measures

Full Information

First Posted
July 15, 2008
Last Updated
September 28, 2010
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00716027
Brief Title
Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?
Official Title
Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Miriam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
Arm Title
2
Arm Type
Experimental
Arm Description
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.
Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral treatment for weight loss
Intervention Description
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Modified behavioral treatment for weight loss
Intervention Description
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity. In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.
Primary Outcome Measure Information:
Title
weight
Time Frame
weekly for 24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI between 27 and 45 kg/m2 Exclusion Criteria: participating in a weight loss program or taking a weight loss medication currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena R Wing, PhD
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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Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?

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