Clinical trial NCT02574689: Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South
Official title: Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical Activity
Cancer Prevention
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-10-14
Enrollment: 83
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study represents an initial foray into delivering home-based individually-tailored physical activity interventions for cancer risk reduction among African American women in the Deep South.

Detailed description: 80 women will receive the HIPP Intervention or Wellness Contact Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected at baseline, 6 months, and 12 months, along with blood draws.

HIPP Intervention: The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and, emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Computer expert system feedback reports will be based on participants' monthly update survey data and include information on:

1. current stage of motivational readiness for physical activity;
2. increasing self- efficacy (i.e., confidence) for physical activity participation;
3. weighing the pros and cons of engaging in physical activity (decisional balance);
4. social support from family and friends for physical activity participation;
5. outcome expectations (beliefs regarding the consequences of physical activity participation);
6. perceived enjoyment of physical activity;
7. how the participant compares to her prior responses (progress feedback);
8. how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
9. self monitoring of physical activity behavior (using pedometers and activity logs to track the total steps and minutes of moderate intensity physical activity per day).

The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. Intervention participants will also receive tip sheets addressing physical activity barriers specific to African American women in the Deep South (as identified during our focus groups and comprehensive literature review).

Wellness Contact Control Condition: Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society (ACS) website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.

Eligibility criteria: Inclusion Criteria:

* African American
* Post-menopausal (defined as not having menstrual periods for at least 12 months)
* Not taking hormone replacement therapy
* Healthy (BMI 18.5-40; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).
* Not taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
* Not planning to move from the area for the next 12 months
* Willing to be randomized to either study arm and adhere to study protocol

Primary outcomes:
measure: 7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
timeFrame: baseline and 6 months
measure: 7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
timeFrame: baseline and 12 months
Secondary outcomes:
measure: 6 minute walk test
timeFrame: baseline, 6 months, 12 months
measure: body mass index
timeFrame: baseline, 6 months, 12 months
measure: waist circumference
timeFrame: baseline, 6 months, 12 months
measure: body impedance analyses
timeFrame: baseline, 6 months, 12 months
measure: Social Support for exercise scale
timeFrame: baseline, 6 months, 12 months
measure: Outcome expectations scale
timeFrame: baseline, 6 months, 12 months
measure: Physical Activity Enjoyment scale
timeFrame: baseline, 6 months, 12 months
measure: accelerometers
timeFrame: baseline, 6 months, 12 months
measure: Stages of Readiness Measure
timeFrame: baseline, 6 months, 12 months
measure: Self -Efficacy for physical activity scale
timeFrame: baseline, 6 months, 12 months
measure: processes of change measure
timeFrame: baseline, 6 months, 12 months
measure: Decisional Balance scale
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Dori Pekmezi, PhD
role: PRINCIPAL_INVESTIGATOR
References: