ObesityWORDNCT02169947
Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
A study testing Weight loss core and Weight loss core plus maintenance in people with Obesity, run by University of Arkansas at 1 site in United States.
Trial summary
The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight loss core and Weight loss core plus maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2012to 28 Feb 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Aged 18 and older
- Have a BMI ) > 25 kg/m²
- Associated with a participating church through membership or participation in a church activity
- Free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component
- Individuals taking sulfonylureas who have a letter from their doctor supporting their participation in the study will be considered eligible
Who cannot join
- Not had a heart attack or stroke in the past 6 months
- Not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin)
- Not pregnant, not pregnant in the previous six months, or lactating
- Not enrolled in another weight reduction program
- Agree to complete the program assigned to them
- Never had weight loss surgery
- Not have lost more than 10% body weight in the previous 6 months
- Not have a clinically significant medical condition likely to impact weight or any condition that makes it unlikely the participant would be available to follow the protocol for 18 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.
- Conditions
- Obesity
- Being tested
- Weight loss core, Weight loss core plus maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss coreBehavioural
The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
Weight loss core plus maintenanceBehavioural
The intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss core | Active comparator | Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program. Receives: Behavioral: Weight loss core |
| Weight loss core plus maintenance | Experimental | Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions. Receives: Behavioral: Weight loss core; Behavioral: Weight loss core plus maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from 6 months to 18 months
Measured: Change from 6 months to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start1 May 2012
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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 ArkansasThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Karen Yeary, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169947
- Sponsor's protocol ID
- 134125
- Other IDs
- 2P20MD002329-06
- Acronym
- WORD
- Status last verified
- Mar 2018
- First submitted
- 17 Jun 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
- ClinicalTrials.gov ID
- NCT02169947
- Acronym / sponsor ID
- WORD / 134125
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 May 2012 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 23 Jun 2014 (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 WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss core | Active comparator | Behavioral: Weight loss coreParticipants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program. |
| Weight loss core plus maintenance | Experimental | Behavioral: Weight loss core, Behavioral: Weight loss core plus maintenanceParticipants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- African American
- Aged 18 and older
- Have a BMI ) > 25 kg/m²
- Associated with a participating church through membership or participation in a church activity
- Free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component
Key exclusion criteria (8 listed)
- Not had a heart attack or stroke in the past 6 months
- Not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin)
- Not pregnant, not pregnant in the previous six months, or lactating
- Not enrolled in another weight reduction program
- Agree to complete the program assigned to them
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 |
|---|---|---|
| Weight loss coreThe weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program. | Behavioural | Weight loss core, Weight loss core plus maintenance |
| Weight loss core plus maintenanceThe intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions. | Behavioural | Weight loss core plus maintenance |
Primary outcome
Change in weight from 6 months to 18 months
Time frame: Change from 6 months to 18 months
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 Mar 2018.
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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.
Karen Yeary, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss core and Weight loss core plus maintenance in people with Obesity, run by University of Arkansas 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 8 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 Mar 2018. 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?
Change in weight from 6 months to 18 months (time frame: Change from 6 months to 18 months). 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 29 Mar 2018.