Overview

This trial is active, not recruiting.

Conditions physical activity, behavior, overweight, motor activity
Treatments adaptive goals, reinforcement, static goals
Sponsor Arizona State University
Start date February 2014
End date December 2014
Trial size 100 participants
Trial identifier NCT02053259, ASU-SNHP01

Summary

The purpose of this study is to develop and evaluate adaptive goal setting and feedback interventions (Adaptive Interventions) to promote physical activity behaviors and compare it to static physical activity interventions (Static Interventions) using two levels of goal setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All four groups will receive the intervention via a semi-automated text message system developed by the investigators study team.

The primary aim of this study will be to:

1. Evaluate whether the adaptive interventions result in greater change in physical activity (pedometer-measured steps/day) compared to the static Intervention groups. HYPOTHESES: Participants in the adaptive interventions will increase their steps/day more than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.

The secondary aims of this study will be to:

2. Evaluate the effectiveness of the adaptive and static goal interventions in improving anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES: Participants in the adaptive interventions will show greater improvements in fitness, lean and fat body mass, and serum biomarkers than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.

3. to assess participants' satisfaction with the overall program.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
Adaptive Goals, Reinforcement
adaptive goals
reinforcement
(Experimental)
Adaptive Goals, No Reinforcement
adaptive goals
(Experimental)
Static Goals, Reinforcement
reinforcement
static goals
(Active Comparator)
Static Goals, No reinforcement
static goals

Primary Outcomes

Measure
The primary outcome will be change in Fitbit-measured steps/day and moderate-to-vigorous physical activity between study arms.
time frame: Daily for 4 months

Secondary Outcomes

Measure
The secondary outcome will be change in fitness (VO2max) between study arms.
time frame: Baseline and 4 months
A secondary outcome will be change in body mass index and body composition measured by Dual-energy X-Ray Absorptiometry (DEXA) between study arms.
time frame: Baseline and 4 months
A secondary outcome will be change iAortic pulse wave velocity assessed with the SphymocorTM between study arms.
time frame: Baseline and 4 months
A secondary outcome will be changes to cardiovascular-disease (CVD) risk biomarkers and inflammatory markers (e.g. glucose, insulin, lipids, adhesion molecules and hemostatic factors) measured through venous blood using commercially available assays.
time frame: Baseline and 4 months
A secondary outcome will be change in self-reported physical activity measured by the International Physical Activity Questionnaire (IPAQ).
time frame: Baseline and 4 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - women and men of all races/ethnicities living in Maricopa County, Arizona. Exclusion Criteria: - be between 18 and 60 years old - currently not exceeding physical activity recommendations determined by the International Physical Activity Questionnaire (IPAQ short form). - not have a medical condition based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) that requires supervised physical activity - not taking medication(s) that would prohibit a moderate intensity physical activity program - have a body mass index between 25 and 55 kg/m2 - not be currently pregnant or planning to become pregnant in the next 4 months - not be planning to leave Maricopa County for 10 days or more in the next 4 months - not planning to move from Maricopa County in the next 4 months - not currently in another physical activity, diet, or weight loss program (e.g. weight watchers) - have access to Microsoft Windows (XP, Vista, 7, 8) or Mac (10.5+) operating systems on computer with a USB port on a daily basis - have daily access to email and the internet - have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.

Additional Information

Official title Walking Intervention Through Texting Study: A Factorial Trial
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Arizona State University.