Behavior, HealthNCT03861546
Developing a Lifestyle Intervention for South Asians
A study testing Healthy lifestyle Shared Medical Appointment (SMA) program in people with Behavior, Health and Pre Diabetes, run by Emory University at 1 site in United States.
Trial summary
This study aims to test the hypothesis that a culturally tailored lifestyle intervention can improve health behaviors among South Asians with prediabetes and diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavior, Health, Pre Diabetes, Diabetes
- What is being tested?
- Healthy lifestyle Shared Medical Appointment (SMA) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2019to 23 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years;
- confirmed diagnosis of prediabetes or T2D (documented A1c of ≥ 5.7%, 2-hour post-load glucose of >140, or FBG of >100);
- a family member or peer willing to participate and attend all sessions as a social influencer;
- proficiency in English of at least one member of each dyad,
- willingness to provide written consent.
Who cannot join
- type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced);
- malignancy or life-threatening illness with life expectancy of <5 years;
- end-stage disease or serious illness that prohibits participation (e.g. end-stage renal disease or class IV congestive heart failure);
- inability to perform unsupervised physical activity;
- pregnancy;
- diagnosed cognitive deficits or limited decision-making capacity;
- alcohol or substance abuse;
- homelessness or no fixed address.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Family Medicine Clinic
Atlanta, Georgia, 30322
About this study
Official title: Better Together: Leveraging Primary Care and Social Network Resources to Create a Patient-centered Approach to Improve Diabetes Among South Asians
This study aims to test the hypothesis that a culturally tailored lifestyle intervention can improve health behaviors among South Asians with prediabetes and diabetes
Read the detailed description
This pre-post pilot study is a 16 week lifestyle program for South Asians with prediabetes or diabetes in Atlanta. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight.
- Conditions
- Behavior, Health, Pre Diabetes, Diabetes
- Being tested
- Healthy lifestyle Shared Medical Appointment (SMA) program
- Keywords
- South Asian adults, Patient-centered approach, Intensive lifestyle interventions, Diabetes
- Medical subject headings
- Health Behavior, Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle Shared Medical Appointment (SMA) programBehavioural
Social network-based, culturally-tailored healthy lifestyle SMA program for high risk SAs will be piloted to collect pre-post data on diet and exercise habits, and to determine feasibility and acceptability. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Biometric measurements (weight, height, blood pressure) will be collected, point of care glucose and lipid testing will be done.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lifestyle Shared Medical Appointment (SMA) program | Experimental | South Asian (SA) adults with prediabetes and Type 2 Diabetes (T2D) that are 'information rich' and have variation in background characteristics will be identified. Dyads (spouses, parent/adolescent or young adult child, peers) will participate in a 16-week culturally-tailored, community-informed pre-post SMA intervention to improve health behaviors. Receives: Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant perceptions of SMA program
Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.
Measured: 4 months
SMA program retention rate
Number of participants retained will be recorded and SMA retention rate will be calculated
Measured: 4 months
Secondary outcomes (6)
Change in body mass index (BMI)
Body Mass Index (BMI) is a number representing person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.
Measured: Baseline, 4 months, and 12 months
Change in blood pressure
Blood pressure will be measured pre- and post- intervention
Measured: Baseline, 4 months, and 12 months
Change in blood cholesterol level
Cholesterol level will be measured by blood test pre- and post- intervention
Measured: Baseline, 4 months, and 12 months
Change in physical activity daily minutes
Daily minutes of moderate intensity exercise will be self reported by participants
Measured: Baseline, 4 months, and 12 months
Change in step counts
Daily step counts (using wearable perdometer) will be recorded.
Measured: Baseline, 4 months, and 12 months
Change in diet
Pre-post assessment of change in consumption will be done using food frequency questionnaire. It has 16 questions that assess dietary habits over the past week.
Measured: Baseline, 4 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start3 Mar 2019
- Primary completion23 Jun 2019
- Study completion23 Jun 2019
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 Behavior, HealthStudies of the same condition, open and under way.
- More trials run by Emory 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megha Kumudchandra Shah, Emory University
- Investigators
- Megha K Shah, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861546
- Sponsor's protocol ID
- IRB00097724
- Status last verified
- Nov 2019
- First submitted
- 1 Mar 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah MK, Naing S, Kurra N, Weber MB, Islam N, Ali MK, Narayan KMV. A culturally adapted, social support-based, diabetes group visit model for Bangladeshi adults in the USA: a feasibility study. Pilot Feasibility Stud. 2022 Jan 24;8(1):18. doi: 10.1186/s40814-022-00974-9.
PubMed 35074000
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Together: Leveraging Primary Care and Social Network Resources to Create a Patient-centered Approach to Improve Diabetes Among South Asians
- ClinicalTrials.gov ID
- NCT03861546
- Acronym / sponsor ID
- IRB00097724
- Conditions
- Behavior, Health, Pre Diabetes, Diabetes
- Keywords
- South Asian adults, Patient-centered approach, Intensive lifestyle interventions, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 23 Jun 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 4 Mar 2019 (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.
This study aims to test the hypothesis that a culturally tailored lifestyle intervention can improve health behaviors among South Asians with prediabetes and diabetes
Detailed description
This pre-post pilot study is a 16 week lifestyle program for South Asians with prediabetes or diabetes in Atlanta. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy lifestyle Shared Medical Appointment (SMA) program | Experimental | Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) programSouth Asian (SA) adults with prediabetes and Type 2 Diabetes (T2D) that are 'information rich' and have variation in background characteristics will be identified. Dyads (spouses, parent/adolescent or young adult child, peers) will participate in a 16-week culturally-tailored, community-informed pre-post SMA intervention to improve health behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years;
- confirmed diagnosis of prediabetes or T2D (documented A1c of ≥ 5.7%, 2-hour post-load glucose of >140, or FBG of >100);
- a family member or peer willing to participate and attend all sessions as a social influencer;
- proficiency in English of at least one member of each dyad,
- willingness to provide written consent.
Key exclusion criteria (8 listed)
- type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced);
- malignancy or life-threatening illness with life expectancy of <5 years;
- end-stage disease or serious illness that prohibits participation (e.g. end-stage renal disease or class IV congestive heart failure);
- inability to perform unsupervised physical activity;
- pregnancy;
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 |
|---|---|---|
| Healthy lifestyle Shared Medical Appointment (SMA) programSocial network-based, culturally-tailored healthy lifestyle SMA program for high risk SAs will be piloted to collect pre-post data on diet and exercise habits, and to determine feasibility and acceptability. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Biometric measurements (weight, height, blood pressure) will be collected, point of care glucose and lipid testing will be done. | Behavioural | Healthy lifestyle Shared Medical Appointment (SMA) program |
Primary outcome
Participant perceptions of SMA program
Time frame: 4 months
Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.
SMA program retention rate
Time frame: 4 months
Number of participants retained will be recorded and SMA retention rate will be calculated
6 secondary outcomes
Change in body mass index (BMI)
Time frame: Baseline, 4 months, and 12 months
Change in blood pressure
Time frame: Baseline, 4 months, and 12 months
Change in blood cholesterol level
Time frame: Baseline, 4 months, and 12 months
Change in physical activity daily minutes
Time frame: Baseline, 4 months, and 12 months
Change in step counts
Time frame: Baseline, 4 months, and 12 months
Change in diet
Time frame: Baseline, 4 months, and 12 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 18 Nov 2019.
- Derived from this study: PubMed 35074000Shah MK, Naing S, Kurra N, Weber MB, Islam N, Ali MK, Narayan KMV. A culturally adapted, social support-based, diabetes group visit model for Bangladeshi adults in the USA: a feasibility study. Pilot Feasibility Stud. 2022 Jan 24;8(1):18. doi: 10.1186/s40814-022-00974-9.
- 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.
Megha K Shah, MD principal investigator
Emory 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 Healthy lifestyle Shared Medical Appointment (SMA) program in people with Behavior, Health and Pre Diabetes, run by Emory 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 5 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 18 Nov 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?
Participant perceptions of SMA program (time frame: 4 months). 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?
On the ClinicalTrials.gov record for NCT03861546, 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 18 Nov 2019.