ObesityNCT00939081
Community Based Obesity Prevention Among Blacks
A study testing Adaptive step recommendation and 10,000 step/day recommendation in people with Obesity, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Adaptive step recommendation and 10,000 step/day recommendation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Ages 25 and over
- BMI 25 and over
- English fluency
- Not currently pregnant
- No restrictions to ambulatory activity
Who cannot join
- Current pregnancy
- Childbearing in the past 12 months
- History of myocardial infarction or stroke in last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Long-term promotion of physical activity is necessary to achieve obesity prevention. This represents a particular challenge for our intervention design, as few studies have demonstrated positive long-term physical activity promotion outcomes among Black women. We have demonstrated the utility of pedometers among low income, ethnically diverse populations. The efficacy of pedometer utilization for the prevention of weight gain, however, hinges on long-term utilization of the devices. We hypothesize that recommendation for the step count attainment may affect individual's long-term utilization of pedometers, as well as physical activity levels and BMI.
This study is a 24-week experimental trial to examine whether intervention recommendations promote long-term adherence to a pedometer-based physical activity regimen. A two-group, block design will be used in the proposed study. Eligible women will be randomly assigned to one of two experimental conditions (n=75 per condition): 1) receiving a 10,000 steps/day recommendation and 3 health education sessions or 2) receiving an adaptive recommendation and an obesity prevention intervention. The adaptive step recommendation will update participants' recommended step counts, starting at 7,000 steps/day, then 8,000 steps/day, then finally 10,000 steps/day. Participants in the adaptive recommendation group will be provided with 3 educational sessions and will be asked to report their daily progress on weight maintenance goals via text message.
Participants will be provided pedometers and will be asked to wear them every day of the 24-week trial period.
Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline, 12 weeks and 24 weeks post-baseline.
- Conditions
- Obesity
- Being tested
- Adaptive step recommendation, 10,000 step/day recommendation
- Keywords
- Obesity, Women's health, Minority health, Obesity prevention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive step recommendationBehavioural
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.
10,000 step/day recommendationBehavioural
Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Adaptive step recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the pedometer-based physical activity regimen
Measured: 24 weeks post baseline
Secondary outcomes (2)
Change in physical activity
Measured: 24 weeks post baseline
Change in BMI
Measured: 24 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Bennett, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939081
- Sponsor's protocol ID
- 2794
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2009
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24246427
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Obesity Prevention Among Blacks
- ClinicalTrials.gov ID
- NCT00939081
- Acronym / sponsor ID
- 2794
- Conditions
- Obesity
- Keywords
- Obesity, Women's health, Minority health, Obesity prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Long-term promotion of physical activity is necessary to achieve obesity prevention. This represents a particular challenge for our intervention design, as few studies have demonstrated positive long-term physical activity promotion outcomes among Black women. We have demonstrated the utility of pedometers among low income, ethnically diverse populations. The efficacy of pedometer utilization for the prevention of weight gain, however, hinges on long-term utilization of the devices. We hypothesize that recommendation for the step count attainment may affect individual's long-term utilization of pedometers, as well as physical activity levels and BMI.
This study is a 24-week experimental trial to examine whether intervention recommendations promote long-term adherence to a pedometer-based physical activity regimen. A two-group, block design will be used in the proposed study. Eligible women will be randomly assigned to one of two experimental conditions (n=75 per condition): 1) receiving a 10,000 steps/day recommendation and 3 health education sessions or 2) receiving an adaptive recommendation and an obesity prevention intervention. The adaptive step recommendation will update participants' recommended step counts, starting at 7,000 steps/day, then 8,000 steps/day, then finally 10,000 steps/day. Participants in the adaptive recommendation group will be provided with 3 educational sessions and will be asked to report their daily progress on weight maintenance goals via text message.
Participants will be provided pedometers and will be asked to wear them every day of the 24-week trial period.
Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline, 12 weeks and 24 weeks post-baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10,000 step/day recommendation | Active comparator | Behavioral: 10,000 step/day recommendationParticipants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months. |
| Adaptive recommendation | Experimental | Behavioral: Adaptive step recommendationThe 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Ages 25 and over
- BMI 25 and over
- English fluency
- Not currently pregnant
Key exclusion criteria (3 listed)
- Current pregnancy
- Childbearing in the past 12 months
- History of myocardial infarction or stroke in last 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive step recommendationParticipants 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. | Behavioural | Adaptive recommendation |
| 10,000 step/day recommendationParticipants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months. | Behavioural | 10,000 step/day recommendation |
Primary outcome
Adherence to the pedometer-based physical activity regimen
Time frame: 24 weeks post baseline
2 secondary outcomes
Change in physical activity
Time frame: 24 weeks post baseline
Change in BMI
Time frame: 24 weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Results publication: PubMed 24246427Steinberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Bennett, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive step recommendation and 10,000 step/day recommendation in people with Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the pedometer-based physical activity regimen (time frame: 24 weeks post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00939081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.