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The Healthy Weight for Life Program (HWL)

Primary Purpose

Overweight, Obesity, Compliance Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight loss intervention
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Worksite, group weight loss, behavioral components

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention Group

    Control Group (delayed intervention)

    Arm 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

    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.

    Outcomes

    Primary Outcome Measures

    Change in Body Weight
    Fasting Values

    Secondary Outcome Measures

    *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

    Full Information

    First Posted
    November 9, 2011
    Last Updated
    November 10, 2011
    Sponsor
    Tufts University
    Collaborators
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01470222
    Brief Title
    The Healthy Weight for Life Program
    Acronym
    HWL
    Official Title
    The Healthy Weight for Life Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tufts University
    Collaborators
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Obesity, Compliance Behavior
    Keywords
    Worksite, group weight loss, behavioral components

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    175 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Control Group (delayed intervention)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Weight loss intervention
    Intervention Description
    Menu-based recommendations to consume a high fiber, low glycemic load diet with education on nutrition and behavior change.
    Primary Outcome Measure Information:
    Title
    Change in Body Weight
    Description
    Fasting Values
    Time Frame
    Change from baseline weight to weeks 6, 10, 16, 20, 24.
    Secondary Outcome Measure Information:
    Title
    *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.
    Description
    questionnaire measures
    Time Frame
    *Change from baseline to weeks 10 and 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sai Krupa Das, Ph.D.
    Organizational Affiliation
    Tufts University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23512619
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    23426035
    Citation
    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.
    Results Reference
    derived

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    The Healthy Weight for Life Program

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