The Healthy Weight for Life Program (HWL)

Tufts University

Status: Completed

Conditions: Overweight; Compliance Behavior; Obesity

Treatments: Other: Weight loss intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01470222

9279

Details and patient eligibility

About

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).

Enrollment: 175 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Monthly, all-worksite activities will be implemented to raise awareness of healthy nutrition for weight control throughout the worksite. The purpose of the all-worksite activities is: a) to create a supportive worksite-wide atmosphere for the individuals enrolling in the weight loss support group, and b) to provide low-level weight loss support for individuals who wish to prevent weight gain. Individuals with eligible weight (defined as BMI ≥ 25 kg/m2) without medical contradictions to weight loss, who wish to join a support group to lose weight, may enroll in the worksite weight control support group that will meet weekly for the first 10 weeks and then monthly until the end of the 6-month intervention

Treatment:

Other: Weight loss intervention

Control Group (delayed intervention)

Experimental group

Description:

At the end of the study period, subjects will receive a 2-month structured intervention that will provide all of the resources and materials given to the intervention worksite as well as weight control support groups for employees interested in losing weight.

Treatment:

Other: Weight loss intervention