NCT01793064

Brief Summary

The purpose of this study is to develop and evaluate an adaptive shaping intervention based on Behavioral Economics and Operant principles to promote physical activity behaviors (adaptive group) and compare to a static physical activity intervention (static group) using a two-group randomized controlled trial design. Participants will include 20 overweight men and women (BMI 25-35 kg/m2) between 18 to 55 years. Both groups will receive the following components: 1) a pedometer, 2) self-monitoring of physical activity, 3) brief educational materials, 4) motivational prompts, 5) physical activity goals, and 6) small financial incentives. The Adaptive Intervention (AI) group will receive adaptive goals and feedback based on percentiles and a "moving" window of their recent physical activity, with incentives linked to goal attainment. Comparison intervention participants will receive the static 10,000 steps per day goal, with matching incentive amounts but without incentives linked to goal attainment. The study will compare differences in goal setting and shaping procedures that aim to increase physical activity behavior. Primary aims include:

  1. 1.To determine whether physical activity (pedometer-measured steps/day) in both the Adaptive and Static interventions increased compared to their respective baselines. Hypothesis: Both the adaptive and static interventions will result in increased physical activity over 6 months.
  2. 2.To evaluate whether the Adaptive Intervention results in greater change in physical activity (pedometer-measured steps/day) compared to the Static Intervention. Hypothesis: The adaptive intervention will result in significantly greater physical activity, measured by pedometer, compared to the static intervention over 6 months.
  3. 3.To assess participants' satisfaction with the overall program. Hypothesis: Adaptive Intervention participants will report greater overall satisfaction with the intervention than the Static Intervention participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

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

Study Start

First participant enrolled

June 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

February 13, 2013

Last Update Submit

January 13, 2014

Conditions

Physical Activity

Keywords

Pedometer,adaptive,exercise,reinforcement,goal setting,technology,email,weight lossmHealtheHealth

Outcome Measures

Primary Outcomes (1)

  • Physical activity measured daily over 6 months by Omron pedometers (HJ-720ITC) .

    Participants in both groups will be provided an Omron (HJ-720ITC) pedometer on the first day of the baseline phase, and will continue to use the pedometer throughout the entire study.

    6 months

Secondary Outcomes (1)

  • Satisfaction Survey

    6 months

Study Arms (2)

Adaptive Intervention Group (AI)

EXPERIMENTAL

Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.

Behavioral: Adaptive Intervention (AI)

Static Intervention group (SI)

ACTIVE COMPARATOR

Static Intervention group (SI) receives a static "usual care" goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website.

Behavioral: Static Intervention (SI)

Interventions

Adaptive Intervention (AI)BEHAVIORAL

Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.

Adaptive Intervention Group (AI)
Static Intervention (SI)BEHAVIORAL

Static Intervention group (SI) receives a static "usual care" goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website.

Static Intervention group (SI)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Live in San Diego County.
  • Be between 18 and 55 years old.
  • Currently not exceeding 1,000 MET-minutes per week of physical activity determined by the International Physical Activity Questionnaire (IPAQ short form).
  • Not suffering from a medical condition or taking medication(s) that would prohibit one from adopting a moderate intensity physical activity program.
  • Have a body mass index between 25 and 35 kg/m2.
  • Not currently pregnant.
  • Familiar with email and access to email and the internet daily,
  • Not planning to leave San Diego County for more than 10 days over the next 6 months.
  • Not planning to move away from San Diego County in the next 6 months.
  • Potential participants must have access to Microsoft Windows (XP, Vista, or windows 7) on a daily basis. If they do not, they would need to have daily access to and use Windows virtualization software (e.g. Parallels, VMware) for an Apple operating system.

You may not qualify if:

  • Does not live in Dan Diego.
  • Individuals under the age of 18 or over 55.
  • Those who exceed 1,000 met-minutes of physical activity per week determined by the International Physical Activity Questionnaire (IPAQ short form).
  • Suffering from a medical condition or taking medication which will prohibit one from adopting a moderate intensity physical activity program.
  • Does not have a BMI between 25 and 35 kg/m2.
  • Currently Pregnant.
  • Unfamiliar with email, or does not have access to the internet and email daily.
  • Planning to leave San Diego for more than ten days.
  • Planning to move from San Diego in the next 6 months.
  • Does not have access to Microsoft Windows or a Windows virtualization software for an Apple operating system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

Related Publications (1)

  • Adams MA, Sallis JF, Norman GJ, Hovell MF, Hekler EB, Perata E. An adaptive physical activity intervention for overweight adults: a randomized controlled trial. PLoS One. 2013 Dec 9;8(12):e82901. doi: 10.1371/journal.pone.0082901. eCollection 2013.

    PMID: 24349392RESULT

MeSH Terms

Conditions

Motor ActivityWeight Loss

Condition Hierarchy (Ancestors)

BehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Adams, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Exercise and Wellness Program, School of Nutrition and Health Promotion, College of Health Solutions.

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

US(1)