NCT00939081

Brief Summary

The purpose of this study is to examine whether pedometer step count recommendations (10,000 steps/day versus an adaptive recommendation) are differentially associated with the primary outcome of adherence to the pedometer-based physical activity regimen and the secondary outcomes of change in physical activity and body mass index (BMI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

July 10, 2009

Last Update Submit

July 28, 2014

Conditions

Obesity

Keywords

ObesityWomen's healthMinority healthObesity prevention

Outcome Measures

Primary Outcomes (1)

  • Adherence to the pedometer-based physical activity regimen

    24 weeks post baseline

Secondary Outcomes (2)

  • Change in physical activity

    24 weeks post baseline

  • Change in BMI

    24 weeks post baseline

Study Arms (2)

10,000 step/day recommendation

ACTIVE COMPARATOR

Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.

Behavioral: 10,000 step/day recommendation

Adaptive recommendation

EXPERIMENTAL

The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day. The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.

Behavioral: Adaptive step recommendation

Interventions

Adaptive step recommendationBEHAVIORAL

Participants in this group receive 3 education sessions: at baseline, at 3 months and at 6 months. The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day. The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.

Adaptive recommendation
10,000 step/day recommendationBEHAVIORAL

Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.

10,000 step/day recommendation

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Ages 25 and over
  • BMI 25 and over
  • English fluency
  • Not currently pregnant
  • No restrictions to ambulatory activity

You may not qualify if:

  • Current pregnancy
  • Childbearing in the past 12 months
  • History of myocardial infarction or stroke in last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Steinberg DM, Levine EL, Askew S, Foley P, Bennett GG. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. J Med Internet Res. 2013 Nov 18;15(11):e244. doi: 10.2196/jmir.2844.

    PMID: 24246427RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gary Bennett, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

June 1, 2014

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)