The Healthy Weight for Life Program

Obesity Clinical Trial

— HWL  

Official title:

The Healthy Weight for Life Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470222
• Other study ID #: 9279
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: November 10, 2011
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compliance Behavior
• Obesity
• Overweight

Intervention

Other:
• Weight loss intervention
Menu-based recommendations to consume a high fiber, low glycemic load diet with education on nutrition and behavior change.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Fasting Values	Change from baseline weight to weeks 6, 10, 16, 20, 24.	No
Secondary	*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.	questionnaire measures	*Change from baseline to weeks 10 and 24	No