NCT01584596

Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 35 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The Lower Mississippi Delta (LMD) population is characterized by high levels of overweight and obesity, which are the result of long-term disruptions in energy imbalance where dietary energy intake has exceeded energy expenditure associated with physical activity. To address this issue, the overall goal of this project is to determine ways in which the U.S. Department of Health and Human Services and U.S. Department of Agriculture Dietary Guidelines for Americans (2005) physical activity recommendations can be effectively adapted for the LMD population. Phase I of this study was completed in early 2011.

Detailed description

During Phase I, we determined the feasibility of adapting physical activity recommendations by incorporating pedometers (step-counters) as self-monitoring tools within the context of an education program. Lessons learned from the feasibility study have been incorporated into the design of the current proposed Phase II program. This study will be an appropriately powered, randomized controlled effectiveness trial of physical activity and adapted dietary guidelines (DG) eating patterns to reduce unhealthy weight gain. The Steps Ahead study will use the step-based physical activity recommendations identified in Phase I. Participants will be randomized and orientated into one of two groups. One group will be an adapted DG group who will receive education on the adapted DG guidelines. The second group will be an adapted DG plus physical activity group who will also receive the adapted DG guidelines education plus a physical activity intervention. The diet and physical activity recommendations have been developed to be used as low-intensity interventions in order to ensure maximal sustainability in the population. This intervention will be undertaken in East Baton Rouge parish, an area of the Delta region which contains communities and neighborhoods representative of the broader Delta region.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Adapted Dietary Guidelines	This group will receive dietary counseling to reduce their overall dietary food intake by 100 kcal/day, as prescribed by the dietary guidelines for the prevention of weight gain, and to follow an adapted eating pattern (to be determined from formative research in Phase I research). The education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. During the adoption phase, participants will meet for one session per week for the first four weeks. During this session their interim weight will be recorded before they receive their session. During the adherence phase, participants will be contacted by telephone biweekly by a trained interventionist.
BEHAVIORAL	Adapted Physical Activity Guidelines	The physical activity education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. The adoption phase will be for 1 hour and 45 minutes for the first 4 weeks with classes occurring once per week in conjunction with the DG education classes. During the adoption phase, participants monitor their own walking using pedometers and attend weekly group meetings to review the previous week's walking behaviors, discuss preferred strategies for success, and set personally relevant and incremental steps/day goals. During the adherence phase (the remaining 8 weeks), participants will continue with their self-monitoring and goal-setting (using their pedometers), with reduced contact with the study interventionists over the telephone (biweekly).

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-04-25
• Last updated: 2016-02-05

Locations

1 site across 1 country: United States