The Deep South IVR-based Active Lifestyle Study

NCT02627235 | Completed

• 2 other identifiers: X1312030021R03CA177538
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study represents an initial foray into delivering an Individual Voice Response-based (IVR) physical activity intervention for cancer risk among sedentary adults in the Deep South.

Conditions

Physical Activity

Keywords

Physical Activity; Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• Consumer Satisfaction Survey

  Satisfaction with IVR-based system intervention

  3 months

Secondary Outcomes (10)

• 7 Day Physical Activity Recall

  Baseline and 3 months

• 6 Minute Walk Test

  Baseline and 3 months

• body mass index

  Baseline and 3 months

• waist circumference

  Baseline and 3 months

• body impedance analyses

  Baseline and 3 months

Study Arms (2)

DIAL Intervention

EXPERIMENTAL

The physical activity intervention 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 daily IVR-system call feedback and monthly graphic-based feedback delivered in the mail. In addition, social support, outcome expectations and perceived physical activity enjoyment variables will be assessed at baseline, 30, 60, and 90 days. Responses will be used to select appropriate tailored feedback modules.

Behavioral: DIAL

Wait List Control

ACTIVE COMPARATOR

Access to the intervention 12 weeks following baseline assessment.

Behavioral: Wait List Control

Interventions

DIAL BEHAVIORAL

The physical activity intervention is based on Social Cognitive Theory and includes feedback on physical activity progress via IVR system and monthly graphic-based feedback letters delivered in the mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction.

DIAL Intervention

Wait List Control BEHAVIORAL

Access to DIAL intervention 12 weeks following baseline assessment.

Wait List Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Underactive (\<60 min/week moderate PA)
• Able to speak/read English
• Willing to be assigned to either condition
• Access to a telephone
• Not planning to move from the area in the next 4 months
• Healthy (BMI 18.5-45; 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Dori Pekmezi, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)