Impact of Group Size in Weight Loss Interventions

NCT ID: NCT01165151

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-12-31

Brief Summary

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The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.

Detailed Description

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Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Small group

10-member groups

Group Type EXPERIMENTAL

behavioral weight loss program

Intervention Type BEHAVIORAL

weekly, group-based lifestyle weight loss program

Large group

30-member groups

Group Type ACTIVE_COMPARATOR

behavioral weight loss program

Intervention Type BEHAVIORAL

weekly, group-based lifestyle weight loss program

Interventions

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behavioral weight loss program

weekly, group-based lifestyle weight loss program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults (at least 21 years-old)
* Health insurance coverage with Capital Health Plan (CHP)
* Body mass index BMI between 30-45 kg/m2

Exclusion Criteria

* BMI is less than 30 kg/m2 or greater than 45 kg/m2
* Weight loss \> 10 pounds in past 6 months
* Acute or chronic illnesses for which weight loss is contraindicated
* Unwilling or unable to give informed consent
* Unwilling to accept random assignment
* Unwilling or unable to travel to CHP clinic for assessments and groups
* Likely to relocate out of the area in the next 12 months
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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DK081607-01A1

Identifier Type: -

Identifier Source: org_study_id

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