The Healthy Weight for Life Program

Not Applicable

Completed

• Conditions: Overweight; Obesity; Compliance Behavior

• Registration Number: NCT01470222
• Lead Sponsor: Tufts University

Brief Summary

This study is a randomized controlled pilot of a work site weight control intervention. The purpose of the pilot is to obtain preliminary data for future NIH submissions. Four work sites were identified through a multistage recruiting process. Work sites were randomized to either the intervention group, which will receive the intervention immediately following randomization or the control group which will receive a shortened intervention over a 1-month period, 6 months after the active intervention sites have completed their program. The intervention will consist of a variety of activities conducted over a 6 month period, that are overseen by a work site-Tufts oversight group, including the following optional elements: For overweight and obese individuals, regular support groups for weight loss and prevention of weight regain. For all work site employees irrespective of weight, handouts and posted informational resources on healthy eating, monthly lunchtime seminars, and food sampling to facilitate healthy eating patterns for prevention of weight gain.

Basic online assessments on health and nutrition will be carried out at baseline (week 0) and 24 weeks in all work site employees willing to provide information. More detailed online and in-person assessments will be performed throughout the 24-week study period in the weight loss support group participants (intervention sites) and individuals intending to enroll in the support group (control sites).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2011-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Last Update Submitted: 2011-11-10
• Study First Posted: 2011-11-11
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Willing to sign a consent form.
• BMI during screening ≥25 kg/m2 (eligibility for weight loss support group)
• Participants must not have had any surgical procedures influencing weight regulation to include, but not limited to, gastric bypass, other bariatric surgeries, resection of small or large intestine leading to malabsorption, gastric resection for ulcers or cancer, and esophageal resection
• Intention to follow recommended program and complete outcome assessments and requested self-monitoring.
• Obtain a physician's clearance form

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	Change from baseline weight to weeks 6, 10, 16, 20, 24.	Fasting Values

Secondary Outcome Measures

Name	Time	Method
*Fasting lipid panel and blood glucose, and blood pressure. Frequency and intensity of use of intervention components by intervention worksite support group employees and their relation to weight change over time.	*Change from baseline to weeks 10 and 24	questionnaire measures