NCT03861546

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

March 1, 2019

Last Update Submit

November 15, 2019

Conditions

Behavior, HealthPre DiabetesDiabetes

Keywords

South Asian adultsPatient-centered approachIntensive lifestyle interventionsDiabetes

Outcome Measures

Primary Outcomes (2)

  • Participant perceptions of SMA program

    Physician-participants interviews will be digitally audio-recorded and transcribed verbatim, with de-identified transcripts analyzed.

    4 months

  • SMA program retention rate

    Number of participants retained will be recorded and SMA retention rate will be calculated

    4 months

Secondary Outcomes (6)

  • Change in body mass index (BMI)

    Baseline, 4 months, and 12 months

  • Change in blood pressure

    Baseline, 4 months, and 12 months

  • Change in blood cholesterol level

    Baseline, 4 months, and 12 months

  • Change in physical activity daily minutes

    Baseline, 4 months, and 12 months

  • Change in step counts

    Baseline, 4 months, and 12 months

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Healthy lifestyle Shared Medical Appointment (SMA) program

Interventions

Healthy lifestyle Shared Medical Appointment (SMA) programBEHAVIORAL

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.

Healthy lifestyle Shared Medical Appointment (SMA) program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Family Medicine Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

    PMID: 35074000DERIVED

MeSH Terms

Conditions

Health BehaviorGlucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

BehaviorHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Megha K Shah, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 4, 2019

Study Start

March 3, 2019

Primary Completion

June 23, 2019

Study Completion

June 23, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)