OverweightWeight-WiseNCT01141348
The Weight-Wise Weight Loss Translation Study
A study testing Special Intervention and Delayed Intervention in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 6 sites in United States.
Trial summary
The overall goal of the translational research is to evaluate the processes and outcomes of implementing, in a range of public health agencies, an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women only
- Conditions the study is for
- Overweight, Obesity, Cardiovascular Disease
- What is being tested?
- Special Intervention and Delayed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2009to Jan 2010
- 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 40 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI between 27.5 and 45
- willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
- English-speaking
- able and willing to give informed consent
- household income less than or equal to 250% of federal poverty guidelines.
Who cannot join
- medical or physical limitations to engaging in moderate level physical activity
- medical or other contraindications to weight loss
- history of gastric bypass surgery or scheduled surgery for this purpose
- weight loss of > 20 lbs in the last 3 months
- current use of medication for weight loss
- treatment of psychosis
- diagnosis of Type 1 diabetes.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albemarle Regional Health Services
Elizabeth City, North Carolina, 27907
Davidson County Health Department
Lexington, North Carolina, 27293
Lincoln County Health Department
Lincolnton, North Carolina, 28092
Nash County Health Department
Nashville, North Carolina, 27856
Warren County Health Department
Warrenton, North Carolina, 27589
Forsyth County Health Department
Winston-Salem, North Carolina, 27102
About this study
Official title: Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise
The overall goal of the translational research is to evaluate the processes and outcomes of implementing, in a range of public health agencies, an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. The intervention was originally studied in a single coordinated community health care center/church setting and delivered by research staff. The investigators will evaluate the intervention's translation and test its effectiveness as implemented by existing staff in six public health agencies supported by local community resources.
Read the detailed description
Low-income women in the US have the highest rates of overweight and obesity, putting them at increased risk for diabetes, heart disease, and other chronic illnesses. Because mean body mass index gradually increases during adult life and peaks at 50-59 years of age, low income women between 40-64 years are a group deserving of special attention. While there is sufficient evidence that some behavioral weight management interventions are effective in producing clinically meaningful levels of weight loss with reductions in cardiovascular risk factors and delayed onset of diabetes, there is a research gap in translating these efficacious interventions to real life settings and diverse population groups. Research that seeks to translate effective behavioral weight management interventions from resource-intensive efficacy trials to long-term adoption and implementation by public health settings serving a diverse low-income population is timely and of great public health significance. This translational research can provide important information to decision-makers about evidence-based intervention delivery, resource allocation, and workforce preparation.
The overall goal of the proposed research is to evaluate the processes and outcomes of translating from research to practice an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. Originally studied in a single coordinated community health care center/church setting and delivered by research staff (Weight-Wise Pilot Study), we will evaluate the translation of and test the effectiveness of this intervention as implemented by existing staff in a range of county health departments supported by local community resources.
To evaluate the translation process, we will use the RE-AIM framework, diffusion of innovation theory, and systematic models of adaptation to assess: 1) factors related to reach; contextual or setting-specific factors necessary for successful adoption and implementation; 2) effectiveness of facilitator training and stakeholder collaborations; 3) adaptation and fidelity during implementation; and 4) costs associated with the implementation and outcomes. To test the intervention's effectiveness, we will enroll 240 overweight or obese low-income women, 40-64 years of age, at 6 representative public health agencies. Participants will be randomized to receive a 16-week behavioral weight loss intervention (special intervention group) or usual care (wait listed control group). The primary study outcome at 5 month follow-up is weight change; secondary outcomes include change in blood pressure, dietary intake, physical activity, and quality of life measures.
- Conditions
- Overweight, Obesity, Cardiovascular Disease
- Being tested
- Special Intervention, Delayed Intervention
- Medical subject headings
- Overweight, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Special InterventionBehavioural
16 week behavioral weight loss intervention included 2 hour weekly group sessions
Delayed InterventionBehavioural
During the randomized controlled trial, the Delayed Intervention (DI) group received two newsletters with study updates and general health information. Following the trial, the DI group received a 10-week weight loss program.
| Study group | Role | What they receive |
|---|---|---|
| Special Intervention | Experimental | Not described Receives: Behavioral: Special Intervention |
| Delayed Intervention | Experimental | Not described Receives: Behavioral: Delayed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change difference between baseline and 4 month follow-up
Measured: Baseline and 4 month follow-up
Secondary outcomes (1)
Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up
Measured: Baseline and 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2010
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 OverweightStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Davidson County Health Department, Forsyth County Health Department, Lincoln County Health Department, Nash County Health Department, Albemarle Regional Health Services, Warren County Health Department
- Investigators
- Carmen Samuel-Hodge, PhD, MS, RD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141348
- Sponsor's protocol ID
- 08-0055
- Acronym
- Weight-Wise
- Status last verified
- Jun 2010
- First submitted
- 6 May 2010
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones SA, Evenson KR, Johnston LF, Trost SG, Samuel-Hodge C, Jewell DA, Kraschnewski JL, Keyserling TC. Psychometric properties of the modified RESIDE physical activity questionnaire among low-income overweight women. J Sci Med Sport. 2015 Jan;18(1):37-42. doi: 10.1016/j.jsams.2013.12.007. Epub 2014 Jan 1.
PubMed 24462117
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise
- ClinicalTrials.gov ID
- NCT01141348
- Acronym / sponsor ID
- Weight-Wise / 08-0055
- Conditions
- Overweight, Obesity, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Davidson County Health Department, Forsyth County Health Department, Lincoln County Health Department, Nash County Health Department, Albemarle Regional Health Services, Warren County Health Department
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Jun 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 overall goal of the translational research is to evaluate the processes and outcomes of implementing, in a range of public health agencies, an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. The intervention was originally studied in a single coordinated community health care center/church setting and delivered by research staff. The investigators will evaluate the intervention's translation and test its effectiveness as implemented by existing staff in six public health agencies supported by local community resources.
Detailed description
Low-income women in the US have the highest rates of overweight and obesity, putting them at increased risk for diabetes, heart disease, and other chronic illnesses. Because mean body mass index gradually increases during adult life and peaks at 50-59 years of age, low income women between 40-64 years are a group deserving of special attention. While there is sufficient evidence that some behavioral weight management interventions are effective in producing clinically meaningful levels of weight loss with reductions in cardiovascular risk factors and delayed onset of diabetes, there is a research gap in translating these efficacious interventions to real life settings and diverse population groups. Research that seeks to translate effective behavioral weight management interventions from resource-intensive efficacy trials to long-term adoption and implementation by public health settings serving a diverse low-income population is timely and of great public health significance. This translational research can provide important information to decision-makers about evidence-based intervention delivery, resource allocation, and workforce preparation.
The overall goal of the proposed research is to evaluate the processes and outcomes of translating from research to practice an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. Originally studied in a single coordinated community health care center/church setting and delivered by research staff (Weight-Wise Pilot Study), we will evaluate the translation of and test the effectiveness of this intervention as implemented by existing staff in a range of county health departments supported by local community resources.
To evaluate the translation process, we will use the RE-AIM framework, diffusion of innovation theory, and systematic models of adaptation to assess: 1) factors related to reach; contextual or setting-specific factors necessary for successful adoption and implementation; 2) effectiveness of facilitator training and stakeholder collaborations; 3) adaptation and fidelity during implementation; and 4) costs associated with the implementation and outcomes. To test the intervention's effectiveness, we will enroll 240 overweight or obese low-income women, 40-64 years of age, at 6 representative public health agencies. Participants will be randomized to receive a 16-week behavioral weight loss intervention (special intervention group) or usual care (wait listed control group). The primary study outcome at 5 month follow-up is weight change; secondary outcomes include change in blood pressure, dietary intake, physical activity, and quality of life measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Special Intervention | Experimental | Behavioral: Special Intervention |
| Delayed Intervention | Experimental | Behavioral: Delayed Intervention |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 27.5 and 45
- willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
- English-speaking
- able and willing to give informed consent
- household income less than or equal to 250% of federal poverty guidelines.
Key exclusion criteria (7 listed)
- medical or physical limitations to engaging in moderate level physical activity
- medical or other contraindications to weight loss
- history of gastric bypass surgery or scheduled surgery for this purpose
- weight loss of > 20 lbs in the last 3 months
- current use of medication for weight loss
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 |
|---|---|---|
| Special Intervention16 week behavioral weight loss intervention included 2 hour weekly group sessions | Behavioural | Special Intervention |
| Delayed InterventionDuring the randomized controlled trial, the Delayed Intervention (DI) group received two newsletters with study updates and general health information. Following the trial, the DI group received a 10-week weight loss program. | Behavioural | Delayed Intervention |
Primary outcome
Weight Change difference between baseline and 4 month follow-up
Time frame: Baseline and 4 month follow-up
1 secondary outcome
Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up
Time frame: Baseline and 4 month follow-up
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 10 Jun 2010.
- Derived from this study: PubMed 24462117Jones SA, Evenson KR, Johnston LF, Trost SG, Samuel-Hodge C, Jewell DA, Kraschnewski JL, Keyserling TC. Psychometric properties of the modified RESIDE physical activity questionnaire among low-income overweight women. J Sci Med Sport. 2015 Jan;18(1):37-42. doi: 10.1016/j.jsams.2013.12.007. Epub 2014 Jan 1.
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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.
Carmen Samuel-Hodge, PhD, MS, RD principal investigator
University of North Carolina, Chapel Hill
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Special Intervention and Delayed Intervention in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 6 sites 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 5 inclusion and 7 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 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Weight Change difference between baseline and 4 month follow-up (time frame: Baseline and 4 month follow-up). 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 NCT01141348, 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 10 Jun 2010.