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CompletedNCT01470222HWLUpdated Nov 11, 2011

The Healthy Weight for Life Program

An interventional study of Weight loss intervention in Overweight, Obesity and Compliance Behavior, sponsored by Tufts University. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-11.

Sponsored by Tufts University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Overweight
  • Obesity
  • Compliance Behavior

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Keywords

  • Worksite
  • group weight loss
  • behavioral components
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 175 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
175 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherWeight loss intervention

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

06

What researchers measure

Primary outcomes

  1. Change in Body Weight

    Fasting Values

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

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.

    questionnaire measures

    Time frame: *Change from baseline to weeks 10 and 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23512619 ↗
  • 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. PubMed 23426035 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01470222
Lead sponsor
Tufts University
Collaborators
Massachusetts General Hospital
Responsible party
Susan Roberts (Senior Scientist, Energy Metabolism Laboratory, Tufts University) — Principal investigator
First posted
Nov 11, 2011
Start date
Sep 2010
Primary completion
Mar 2011
Completion
Oct 2011
Last update
Nov 11, 2011

Study contacts

Sai Krupa Das, Ph.D.
principal investigator · Tufts University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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