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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01584596
First received: April 23, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Adapted Dietary Guidelines
Behavioral: Adapted Physical Activity Guidelines
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Steps Ahead, Adapting Physical Activity Guidelines for the Lower Mississippi Delta Population

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Body weight [ Time Frame: Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention) ] [ Designated as safety issue: No ]
    Body weight change


Secondary Outcome Measures:
  • Moderate to Vigorous Physical Activity [ Time Frame: Week 0 and week 13 ] [ Designated as safety issue: No ]
    Accelerometer measured moderate to vigocous physical activity levels


Estimated Enrollment: 114
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adapted Diet and Physical Activity
Adapted diet and physical activity guidelines sessions
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).
Other Name: Pedometer
Active Comparator: Adapted Diet
Adapted dietary guidelines sessions
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.


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

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584596

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter T. Katzmarzyk, Associate Executive Director for Population Science, Professor and Louisiana Public Facilities Authority Endowed Chair, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01584596     History of Changes
Other Study ID Numbers: PBRC11028
Study First Received: April 23, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
physical activity
dietary
adults
pedometer
education

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014