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OpenTrials
Completed

NCT Number: NCT01470222

The Healthy Weight for Life Program

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).

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss Intervention

Other

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

Primary outcomes

  1. Change in Body Weight

    Time frame: Change from baseline weight to weeks 6, 10, 16, 20, 24.

    Fasting Values

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Acronym: HWL

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2011
Registry last updated
Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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