Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00142662 |
| Other study ID # |
252 |
| Secondary ID |
R01HL073775 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 1, 2005 |
| Last updated |
March 26, 2014 |
| Start date |
September 2002 |
| Est. completion date |
August 2005 |
Study information
| Verified date |
January 2008 |
| Source |
Drexel University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
To investigate two cafeteria-based methods of weight gain prevention in overweight men and
women.
Description:
BACKGROUND:
Obesity is a risk factor for a number of adverse medical and psychosocial outcomes. Solving
the obesity problem will require a much greater emphasis on prevention. Treatment research
indicates that interventions focusing directly on the food environment (structured meals and
control of food stimuli) have considerable promise for weight control. Prevention research
has found little support for trying to modify characteristics (e.g., knowledge, beliefs,
skills) of individuals, perhaps because this approach does little to modify the food
environment. The research will be implemented in a workplace cafeteria where employees eat
year-round and where the nutritional composition of the food can be modified.
The study was initiated in response to a Request for Applications issued in October, 2001 on
"Environmental Approaches to the Prevention of Obesity". The Request for Applications was
jointly issued by the National Institute of Diabetes and Digestive and Kidney Diseases, the
National Institute of Environmental Health Sciences, the National Center for Minority Health
and Health Disparities, the Office of Behavioral and Social Sciences Research, and the
National Heart, Lung, and Blood Institute.
DESIGN NARRATIVE:
The influence of two promising interventions on food intake, weight change, and related
outcomes will be investigated. The first intervention consists of a training program aimed
at reducing the energy density of participants' diets inside and outside of the cafeteria.
The second intervention consists of financial incentives to encourage the consumption of
cafeteria foods lower in energy density. Participants will be 195 Caucasian and
African-American men and women between the ages of 21 and 65. They will have a BMI of 23-35
and will have characteristics associated with an increased risk of weight gain. Selection
and intake of lunch foods will be measured with digital photography and cashiers'
computerized records of food purchases. Cafeteria patrons will be randomly assigned to 1) a
measurement-only condition; 2) an intervention designed to teach participants how to reduce
the energy density of their diets; or 3) the reduced energy density intervention plus
financial incentives for choosing cafeteria foods low in energy density. The potential
moderating influence of individual differences characteristics on outcome will also be
evaluated. Outcome measures will be administered repeatedly during the intervention and at
9- and 18-month follow-ups. The assessments will include measures of anthropomorphic and
blood lipid variables, nutritional intake (both in and out of the cafeteria), physical
activity, overeating, eating self-efficacy, and weight-related quality of life.
