An Intergenerational Community Based Participatory Research (CBPR) Intervention to Reduce Appalachian Health Disparities

NCT01373307 | Completed

• 1 other identifier: R01DK081324
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief Summary

The study purpose is to evaluate the effectiveness of a culturally appropriate, faith-placed lay health advisor intervention aimed at increasing fruit and vegetable intake and physical activity among intergenerational Appalachian individuals and families.

Conditions

Overweight; Obesity

Keywords

Overweight; obesity; Appalachian; intergenerational; families; energy balance; group-randomized trial

Outcome Measures

Primary Outcomes (3)

• Change in self-reported fruit and vegetable intake from baseline

  Amount of fruit and vegetable intake is measured using an FFQ, pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing fruit and vegetable intake) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

  Assessed approximately 4 months after baseline

• Change in self-reported physical activity from baseline

  Amount of physical activity is measured using instruments with demonstrated reliability and validity, pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing physical activity) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

  Assessed at approximately 4 months after baseline

• Change in body mass index (BMI) from baseline

  Positive change (i.e., decreasing BMI when indicated, or maintaining BMI when not indicated) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

  Assessed at approximately 4 months after baseline

Secondary Outcomes (3)

• Change in stage of readiness to change each health behavior (i.e., fruit and vegetable intake, physical activity) from baseline

  Assessed approximately 4 months after baseline

• Number of visits completed

  Approximately 4 months after baseline

• Retention (i.e., number of participants who complete all planned assessment timepoints)

  Approximately one year after baseline

Study Arms (2)

Early Intervention

EXPERIMENTAL

Participants are nested in churches which were randomly assigned to receive the intervention first.

Behavioral: LHA-delivered energy balance classes/activities

Delayed Intervention

NO INTERVENTION

Wait-list control group. Participants are nested in churches which were randomly assigned to receive the intervention at a later date. Delayed Intervention participants receive an educational luncheon addressing stress reduction during the window of no intervention.

Interventions

LHA-delivered energy balance classes/activities BEHAVIORAL

4-6 sessions delivered by local LHA to age-appropriate groups (i.e., children/adolescents and adults), based on We Can! And Media Smart Youth curricula.

Early Intervention

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 8 years or above
• Able to provide informed consent/assent

Sponsors & Collaborators

• Nancy Schoenberg: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Faith Moves Mountains

Whitesburg, Kentucky, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nancy Schoenberg, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 14, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: June 1, 2014
• Last Updated: July 13, 2015

Record last verified: 2014-12

Locations

US (1)