Impact of Group Size in Weight Loss Interventions

Florida State University

Status and phase: Completed; Phase 4

Conditions: Weight Loss; Obesity

Treatments: Behavioral: behavioral weight loss program

Study type: Interventional

Funder types: Other

Identifiers

NCT01165151

DK081607-01A1

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Small group

Experimental group

Description:

10-member groups

Treatment:

Behavioral: behavioral weight loss program

Large group

Active Comparator group

Description:

30-member groups

Treatment:

Behavioral: behavioral weight loss program