Clinical trial NCT01470222: The Healthy Weight for Life Program
Official title: The Healthy Weight for Life Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Compliance Behavior
Keywords: Worksite
group weight loss
behavioral components
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2011-11-11
Enrollment: 175
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Change from baseline weight to weeks 6, 10, 16, 20, 24.
Secondary outcomes:
measure: *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.
timeFrame: *Change from baseline to weeks 10 and 24
Other outcomes:
Locations:
Study officials:
affiliation: Tufts University
name: Sai Krupa Das, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.