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

NCT01584596 | Completed Phase 1

• 1 other identifier: PBRC 11028
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

physical activity; dietary; adults; pedometer; education

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight change

  Week 0, 1, 2, 3 and 4 and week 12 (termination of intervention)

Secondary Outcomes (1)

• Moderate to Vigorous Physical Activity

  Week 0 and week 13

Study Arms (2)

Adapted Diet and Physical Activity

EXPERIMENTAL

Adapted diet and physical activity guidelines sessions

Behavioral: Adapted Dietary Guidelines; Behavioral: Adapted Physical Activity Guidelines

Adapted Diet

ACTIVE COMPARATOR

Adapted dietary guidelines sessions

Behavioral: Adapted Dietary Guidelines

Interventions

Adapted Dietary Guidelines BEHAVIORAL

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.

Adapted Diet; Adapted Diet and Physical Activity

Adapted Physical Activity Guidelines BEHAVIORAL

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).

Also known as: Pedometer

Adapted Diet and Physical Activity

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-64 years
• Body mass index (BMI) 25 to 34.9 kg/m2
• Physically capable of undertaking physical activity

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

• 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.

  PMID: 24376252 RESULT

• 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.

  PMID: 25569324 RESULT

• 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.

  PMID: 25687483 RESULT

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Peter T Katzmarzyk, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Executive Director for Population Science, Professor and Louisiana Public Facilities Authority Endowed Chair

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 5, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)