Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT01584596
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.
Looking for future studies?
Notify Me35 year–64 year
All sexes
Interventional
Phase 1 / Phase 2
Baton Rouge, Louisiana, 70808, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Other names: Pedometer
Time frame: Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)
Body weight change
Time frame: Week 0 and week 13
Accelerometer measured moderate to vigocous physical activity levels
Pennington Biomedical Research Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06127251
Behavior, Body Weight
Atlanta, Georgia, United States
View Trial DetailsNCT01809288
Behavior, Body Weight
Bethesda, Maryland, United States
View Trial DetailsNCT00063674
Adherence Interventions, Behavior
Palo Alto, California, United States
View Trial DetailsNCT06471569
Behavior, Body Weight
Durham, North Carolina, United States
View Trial Details