NCT00573482

Brief Summary

The dramatic rise in overweight and obesity during the past several decades can be explained by environmental changes that foster increased energy intake and decreased energy expenditure. There are several reasons to suggest that the most effective approach to weight gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering the energy density of the diet. Our energy density manipulations will be designed to reduce both the fat content and the caloric density of foods served at a cafeteria, which serves as the "food environment" for hospital employees.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

First QC Date

December 12, 2007

Last Update Submit

February 24, 2010

Conditions

Keywords

weight gain preventionobesityoverweightfood environmentThe intervention group received the education in REDE techniquesThe control group received no intervention at all.Both groups were exposed to the food labels and the new lower ED foods.Only the intervention group received the education sessions and only they were eligible for the price reductions.

Outcome Measures

Primary Outcomes (1)

  • Weight

    36 months

Secondary Outcomes (1)

  • Caloric and macro-nutrient intake

    36 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Control (only exposure to the food labels and the new lower ED foods).

Behavioral: control

intervention group

EXPERIMENTAL

Education in REDE techniques plus exposure to the food labels and the new lower ED foods.

Behavioral: REDE

Interventions

REDEBEHAVIORAL

The intervention group received the education in REDE techniques. The intervention in this study comprised four components: * Four group education sessions to introduce the REDE principles of eating; * Approximately 10 new lower energy-dense foods were introduced in the employee cafeteria daily at lunchtime; * Food labels for all foods sold in the employee cafeteria at lunch time, which provided the energy density, calories, and macronutrient content of the prepared cafeteria foods. Prior to the intervention almost no foods had food labels. * Price reductions for lower energy density items. Both groups were exposed to the food labels and the new lower ED foods, but only the intervention group received the education sessions about how to take advantage of the new labels and cafeteria foods and only they were eligible for the price reductions.

intervention group
controlBEHAVIORAL

The control group received no REDE intervention at all. Both groups were exposed to the food labels and the new lower ED foods, but the control group did not receive the education sessions.

control group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • works at one of the two hospitals and eats lunch in the cafeteria 2x per week
  • BMI between 23 and 25

You may not qualify if:

  • current diagnosis of a chronic disease or condition known to affect appetite or body weight
  • currently taking medication known to affect appetite or body weight
  • current pregnancy or plans to become pregnant within the next 24 months
  • current enrollment or plans to enroll within the next 24 months in an organized weight management program
  • plans to terminate employment at the hospital within the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Hospitals

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael R Lowe, Ph.D.

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

September 1, 2002

Study Completion

February 1, 2007

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations