ObesityNCT03614338
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
A study testing Small changes weight loss program in people with Obesity, run by Rush University Medical Center at 1 site in United States.
Trial summary
African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Small changes weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 15 Aug 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-45 kg/m2
- Age 18-75
- Attend one of the West Side partnership churches at least 2 times per month
- Able to attend in-person meetings
- Willing to share their experiences on the West Side ALIVE Facebook page
Who cannot join
- Blood pressure > 170/90 (self-report or during the WSA screening)
- Diabetes treated with insulin
- History of cancer within the past 5 years
- Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.
- Conditions
- Obesity
- Being tested
- Small changes weight loss program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small changes weight loss programBehavioural
This intervention uses a "small-changes" approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Core Participants Weight Loss Program | Experimental | Small changes weight loss program Receives: Behavioral: Small changes weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change from baseline using objectively measured body weight
Measured: 3 months
Secondary outcomes (5)
Blood pressure
Change from baseline
Measured: 3 months
Physical activity
Change from baseline in total minutes of MVPA assessed by accelerometer
Measured: 3 months
Weight loss strategies
Change from baseline on self-reported use of weight loss strategies
Measured: 3 months
Weight
Change from baseline using objectively measured body weight
Measured: 6 months
HbA1c
Change from baseline using a point of care analyzer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start3 Jan 2019
- Primary completion8 May 2019
- Study completion15 Aug 2019
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 Rush University Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa M. Crane, PhD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614338
- Sponsor's protocol ID
- 18070904
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side
- ClinicalTrials.gov ID
- NCT03614338
- Acronym / sponsor ID
- 18070904
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- 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.
African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Core Participants Weight Loss Program | Experimental | Behavioral: Small changes weight loss programSmall changes weight loss program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 25-45 kg/m2
- Age 18-75
- Attend one of the West Side partnership churches at least 2 times per month
- Able to attend in-person meetings
- Willing to share their experiences on the West Side ALIVE Facebook page
Key exclusion criteria (4 listed)
- Blood pressure > 170/90 (self-report or during the WSA screening)
- Diabetes treated with insulin
- History of cancer within the past 5 years
- Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months
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 |
|---|---|---|
| Small changes weight loss programThis intervention uses a "small-changes" approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions. | Behavioural | Core Participants Weight Loss Program |
Primary outcome
Weight
Time frame: 3 months
Change from baseline using objectively measured body weight
5 secondary outcomes
Blood pressure
Time frame: 3 months
Physical activity
Time frame: 3 months
Weight loss strategies
Time frame: 3 months
Weight
Time frame: 6 months
HbA1c
Time frame: 3 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 19 Aug 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small changes weight loss program in people with Obesity, run by Rush University Medical Center 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 5 inclusion and 4 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 19 Aug 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. 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 (time frame: 3 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 19 Aug 2019.