Clinical trial NCT01584596: Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
Official title: Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Keywords: physical activity
dietary
adults
pedometer
education
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 129
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)
Secondary outcomes:
measure: Moderate to Vigorous Physical Activity
timeFrame: Week 0 and week 13
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Peter T Katzmarzyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.