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The Healthy Weight for Life Program (HWL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470222
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : November 11, 2011
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Susan Roberts, 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).


Condition or disease Intervention/treatment Phase
Overweight Obesity Compliance Behavior Other: Weight loss intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Healthy Weight for Life Program
Study Start Date : September 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

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

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




Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: Change from baseline weight to weeks 6, 10, 16, 20, 24. ]
    Fasting Values


Secondary Outcome Measures :
  1. *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. [ Time Frame: *Change from baseline to weeks 10 and 24 ]
    questionnaire measures



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470222


Sponsors and Collaborators
Tufts University
Massachusetts General Hospital
Investigators
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Principal Investigator: Sai Krupa Das, Ph.D. Tufts University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susan Roberts, Senior Scientist, Energy Metabolism Laboratory, Tufts University
ClinicalTrials.gov Identifier: NCT01470222    
Other Study ID Numbers: 9279
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011
Keywords provided by Susan Roberts, Tufts University:
Worksite
group weight loss
behavioral components
Additional relevant MeSH terms:
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Overweight
Body Weight