NCT01165151

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

4.4 years

First QC Date

July 16, 2010

Last Update Submit

March 4, 2015

Conditions

ObesityWeight Loss

Keywords

obesityweight lossgroup size

Outcome Measures

Primary Outcomes (1)

  • change in weight from baseline to month 12

    12 months

Secondary Outcomes (1)

  • adherence to treatment protocol

    12 months

Study Arms (2)

Small group

EXPERIMENTAL

10-member groups

Behavioral: behavioral weight loss program

Large group

ACTIVE COMPARATOR

30-member groups

Behavioral: behavioral weight loss program

Interventions

behavioral weight loss programBEHAVIORAL

weekly, group-based lifestyle weight loss program

Large groupSmall group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)