View Clinical Trial (Medical Research Study)
Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
| City: |
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Baton Rouge |
| State: |
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Louisiana |
| Zip Code: |
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70808 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01584596 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Baton Rouge, Louisiana 70808
United States
Peter Katzmarzyk
Email: doctors@pbrc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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