NCT02053259

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 29, 2020

Completed
Last Updated

September 22, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

January 31, 2014

Results QC Date

March 18, 2020

Last Update Submit

August 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms.

    Given this study used a 2 condition (adaptive vs. static goals) x 2 condition (immediate vs. delayed financial reinforcement) randomized factorial design we report main effects for each condition. Sample sizes for main effects will be 96 participants for each comparison (Adaptive vs. Static goals or Immediate vs. Delayed Reinforcement) as the other condition. Consistent with proper analyses of factorial designs, main effects for the goal setting conditions pool participants across reinforcement conditions, and main effects for reinforcement conditions pool participants across goal setting conditions.

    Daily for 4 months

Secondary Outcomes (5)

  • Change in Fitness (VO2max) Between Study Arms.

    Baseline and 4 months

  • Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.

    Baseline and 4 months

  • Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.

    Baseline and 4 months

  • Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.

    Baseline and 4 months

  • Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).

    Baseline and 4 months

Study Arms (4)

Adaptive Goals with Immediate Reinforcement

EXPERIMENTAL

Adaptive Physical Activity Goals, Immediate Financial Reinforcement

Behavioral: Adaptive GoalsBehavioral: Reinforcement

Adaptive Goals with Delayed Reinforcement

EXPERIMENTAL

Adaptive Physical Activity Goals, Delayed Financial Reinforcement

Behavioral: Adaptive Goals

Static Goals with Immediate Reinforcement

EXPERIMENTAL

Static Physical Activity Goals, Immediate Financial Reinforcement

Behavioral: ReinforcementBehavioral: Static Goals

Static Goals with Delayed Reinforcement

ACTIVE COMPARATOR

Static Physical Activity Goals, Delayed Financial Reinforcement

Behavioral: Static Goals

Interventions

Adaptive GoalsBEHAVIORAL
Adaptive Goals with Delayed ReinforcementAdaptive Goals with Immediate Reinforcement
ReinforcementBEHAVIORAL
Adaptive Goals with Immediate ReinforcementStatic Goals with Immediate Reinforcement
Static GoalsBEHAVIORAL
Static Goals with Delayed ReinforcementStatic Goals with Immediate Reinforcement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women and men of all races/ethnicities living in Maricopa County, Arizona.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State Univertsity, School of Nutrition and Health Promotion

Phoenix, Arizona, 85004, United States

Location

Related Publications (3)

  • Hurley JC, Hollingshead KE, Todd M, Jarrett CL, Tucker WJ, Angadi SS, Adams MA. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults. JMIR Res Protoc. 2015 Sep 11;4(3):e108. doi: 10.2196/resprot.4856.

    PMID: 26362511BACKGROUND
  • Adams MA, Hurley JC, Todd M, Bhuiyan N, Jarrett CL, Tucker WJ, Hollingshead KE, Angadi SS. Adaptive goal setting and financial incentives: a 2 x 2 factorial randomized controlled trial to increase adults' physical activity. BMC Public Health. 2017 Mar 29;17(1):286. doi: 10.1186/s12889-017-4197-8.

  • Phillips CB, Hurley JC, Angadi SS, Todd M, Berardi V, Hovell MF, Adams MA. Delay Discount Rate Moderates a Physical Activity Intervention Testing Immediate Rewards. Behav Med. 2020 Apr-Jun;46(2):142-152. doi: 10.1080/08964289.2019.1570071. Epub 2019 Apr 11.

MeSH Terms

Conditions

Motor ActivityBehaviorOverweight

Interventions

Reinforcement Machine Learning

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Machine LearningArtificial IntelligenceAlgorithmsMathematical Concepts

Limitations and Caveats

Not all of the secondary outcome data have been analyzed and some results are pending review by a journal.

Results Point of Contact

Title
Dr. Marc Adams
Organization
Arizona State University

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, College of Health Solutions

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 3, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2018

Last Updated

September 22, 2021

Results First Posted

July 29, 2020

Record last verified: 2021-08

Locations