The Healthy Weight for Life Program

NCT ID: NCT01470222

Last Updated: 2011-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-10-31

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).

Conditions

Overweight; Obesity; Compliance Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Weight loss intervention

Intervention Type: OTHER

Menu-based recommendations to consume a high fiber, low glycemic load diet with education on nutrition and behavior change.

Control Group (delayed intervention)

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.

Group Type: EXPERIMENTAL

Weight loss intervention

Intervention Type: OTHER

Menu-based recommendations to consume a high fiber, low glycemic load diet with education on nutrition and behavior change.

Interventions

Weight loss intervention

Menu-based recommendations to consume a high fiber, low glycemic load diet with education on nutrition and behavior change.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Susan Roberts

Senior Scientist, Energy Metabolism Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sai Krupa Das, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tufts University

References

Batra P, Das SK, Salinardi T, Robinson L, Saltzman E, Scott T, Pittas AG, Roberts SB. Eating behaviors as predictors of weight loss in a 6 month weight loss intervention. Obesity (Silver Spring). 2013 Nov;21(11):2256-63. doi: 10.1002/oby.20404. Epub 2013 Jul 2.

Reference Type: DERIVED

PMID: 23512619 (View on PubMed)

Salinardi TC, Batra P, Roberts SB, Urban LE, Robinson LM, Pittas AG, Lichtenstein AH, Deckersbach T, Saltzman E, Das SK. Lifestyle intervention reduces body weight and improves cardiometabolic risk factors in worksites. Am J Clin Nutr. 2013 Apr;97(4):667-76. doi: 10.3945/ajcn.112.046995. Epub 2013 Feb 20.

Reference Type: DERIVED

PMID: 23426035 (View on PubMed)

Other Identifiers

9279

Identifier Type: -

Identifier Source: org_study_id