- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584596
Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 35-64 years
- Body mass index (BMI) 25 to 34.9 kg/m2
- Physically capable of undertaking physical activity
- The capability and willingness to give written informed consent, to understand exclusion criteria, and to accept the randomized group assignment
Exclusion Criteria:
- Blood pressure greater than 159 mmHg systolic or 99 mmHg diastolic
- Total cholesterol greater than or equal to 240 mg/dl with LDL-C greater than or equal to 160 mg/dl or TG levels greater than or equal to 300 mg/dl
- Previously undiagnosed or uncontrolled Type 2 diabetes
- A past history and/or physical examination or laboratory findings of a medical condition including but not limited to chronic or recurrent cardiovascular, respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions.
- Musculoskeletal problems interfering with exercise. Immunodeficiency diseases or a positive HIV test.
- Malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled.
- Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise
- Pregnant or breastfeeding or plans to become pregnant within the next 4 months.
- Has taken any form of weight loss medication or medications known to affect weight in the past 30 days.
- Have begun taking any new regular prescription medications within the last 3 months (a 3 month stable dose is allowed)
- Planning on starting any new form of medication within the next 4 months
- Being an athlete or highly and regularly physically active (defined as 20 minutes of vigorous activity 3 times per week or 30 minutes of moderate activity 5 times per week)
- Participants not providing adequate accelerometry data i.e. who have not worn the device during waking hours for a full 7 days will be excluded at Visit 3.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adapted Diet and Physical Activity
Adapted diet and physical activity guidelines sessions
|
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:
|
Active Comparator: Adapted Diet
Adapted dietary guidelines sessions
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)
|
Body weight change
|
Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate to Vigorous Physical Activity
Time Frame: Week 0 and week 13
|
Accelerometer measured moderate to vigocous physical activity levels
|
Week 0 and week 13
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter T Katzmarzyk, PhD, Pennington Biomedical Research Center
Publications and helpful links
General Publications
- Harrington DM, Champagne CM, Broyles ST, Johnson WD, Tudor-Locke C, Katzmarzyk PT. Steps ahead: a randomized trial to reduce unhealthy weight gain in the Lower Mississippi Delta. Obesity (Silver Spring). 2014 May;22(5):E21-8. doi: 10.1002/oby.20684. Epub 2014 Jan 25.
- Harrington DM, Champagne CM, Broyles ST, Johnson WD, Tudor-Locke C, Katzmarzyk PT. Cardiometabolic risk factor response to a lifestyle intervention: a randomized trial. Metab Syndr Relat Disord. 2015 Apr;13(3):125-31. doi: 10.1089/met.2014.0112. Epub 2015 Jan 8.
- Barreira TV, Harrington DM, Schuna JM Jr, Tudor-Locke C, Katzmarzyk PT. Pattern changes in step count accumulation and peak cadence due to a physical activity intervention. J Sci Med Sport. 2016 Mar;19(3):227-231. doi: 10.1016/j.jsams.2015.01.008. Epub 2015 Feb 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 11028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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