ObesityNCT01172340
Diet and Exercise for Underserved Women
A study testing Behavioral and support intervention in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
The purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral and support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2011
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 25-50 years of age
- live in Census tracts with 25% or more below poverty in Columbia, SC
- waist circumference >88 cm
Who cannot join
- insulin-dependent
- pregnant
- moderate exercise contraindicated
- not in control of food choices [institutional setting or restricted diet]
- uncontrolled hypertension
- weight >430 pounds
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Research Center, University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Behavioral/Support Intervention for Diet and Exercise Among Underserved Women
The purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.
Read the detailed description
Overweight and obesity disproportionately impact economically disadvantaged and minority women. Overweight and obese women ages 25 to 50 are recruited from Census tracts with 25% or more residents living below poverty-level income. A skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. The intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.
- Conditions
- Obesity
- Being tested
- Behavioral and support intervention, Wait-listed control group
- Keywords
- behavioral, diet, exercise
- Medical subject headings
- Obesity, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral and support interventionBehavioural
Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
Wait-listed control groupBehavioural
Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure
| Study group | Role | What they receive |
|---|---|---|
| Behavioral and support intervention | Experimental | one individual counseling session with diet and exercise recommendations plus 16 weeks of group sessions, plus 8 weeks of phone followup Receives: Behavioral: Behavioral and support intervention |
| wait-listed control group | Placebo comparator | Controls receive individual counseling session and recommendations, mailed health information, and after post-test measures are offered an abbreviated group-based intervention Receives: Behavioral: Wait-listed control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
waist circumference
waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
Secondary outcomes (9)
dietary fat intake
total dietary fat intake in grams and % of energy intake is assessed via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
saturated dietary fat intake
Saturated fat intake in grams and % of energy intake is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
fruit and vegetable intake
Average daily servings of fruit and vegetables is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
dietary fiber intake
Average daily intake of dietary fiber in grams is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
total energy intake
Total energy intake in kcals is measured via 3-day dietary recall interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
physical activity level
Time spent in light, moderate and vigorous physical activity is estimated from 7 days of accelerometer wear at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
social support
Social support for healthy eating and exercise is measure via interview at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
healthy eating behaviors
Healthy eating behaviors are measured with a validated scaled via interviews at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
exercise self-efficacy
Exercise self-efficacy is measured via a validated scale by interview at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startAug 2007
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Sharpe, University of South Carolina
- Investigators
- Patricia A Sharpe, PhD, MPH, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172340
- Sponsor's protocol ID
- Pro00003053
- Status last verified
- Apr 2019
- First submitted
- 28 Jul 2010
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral/Support Intervention for Diet and Exercise Among Underserved Women
- ClinicalTrials.gov ID
- NCT01172340
- Acronym / sponsor ID
- Pro00003053
- Conditions
- Obesity
- Keywords
- behavioral, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Jul 2010 (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 is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.
Detailed description
Overweight and obesity disproportionately impact economically disadvantaged and minority women. Overweight and obese women ages 25 to 50 are recruited from Census tracts with 25% or more residents living below poverty-level income. A skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. The intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral and support intervention | Experimental | Behavioral: Behavioral and support interventionone individual counseling session with diet and exercise recommendations plus 16 weeks of group sessions, plus 8 weeks of phone followup |
| wait-listed control group | Placebo comparator | Behavioral: Wait-listed control groupControls receive individual counseling session and recommendations, mailed health information, and after post-test measures are offered an abbreviated group-based intervention |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 25-50 years of age
- live in Census tracts with 25% or more below poverty in Columbia, SC
- waist circumference >88 cm
Key exclusion criteria (6 listed)
- insulin-dependent
- pregnant
- moderate exercise contraindicated
- not in control of food choices [institutional setting or restricted diet]
- uncontrolled hypertension
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 |
|---|---|---|
| Behavioral and support interventionIndividual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support | Behavioural | Behavioral and support intervention |
| Wait-listed control groupControls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure | Behavioural | wait-listed control group |
Primary outcome
body weight
Time frame: one year
body weight in pounds is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
waist circumference
Time frame: one year
waist circumference in centimeters is measured at baseline,16-weeks post-intervention, 24 weeks post-intervention, and at one year.
9 secondary outcomes
dietary fat intake
Time frame: one year
saturated dietary fat intake
Time frame: one year
fruit and vegetable intake
Time frame: one year
dietary fiber intake
Time frame: one year
total energy intake
Time frame: one year
physical activity level
Time frame: one year
social support
Time frame: one year
healthy eating behaviors
Time frame: one year
exercise self-efficacy
Time frame: one year
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 22 Apr 2019.
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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.
Patricia A Sharpe, PhD, MPH principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral and support intervention in people with Obesity, run by University of South Carolina 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 3 inclusion and 6 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 22 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
body weight (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2019.