Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05905575

A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults

A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

About this study

Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individual with type 2 diabetes:

  • Self-identification as African American;
  • 40 years or older
  • Type 2 diabetes diagnosis for at least six months;
  • A1c > 7.0% at time of enrollment;
  • Being able to speak and read English;
  • Being able to walk;
  • Having an adult family member/close friend willing to co-participate in the study.

Family members:

  • Adults (18 years or older, with or without T2D);
  • Residing in the same household as the T2D participants;
  • Being a spouse, adult child or sibling; or close friend
  • Being able to walk;
  • Being able to speak and read English.

Exclusion criteria

Individual with T2D and family members:

  • Being pregnant or have an advanced or terminal condition;
  • Being cognitively impaired or unable to provide informed consent;
  • Lack conclusive evidence of T2D for patients with T2D.

Treatment and study plan

Family dyad diabetes intervention

Behavioral

The goals of the intervention are to encourage participants to (1) daily self-manage diabetes and stress; (2) establish a healthy eating pattern; (3) engage in brisk walking of 150 or more minutes a week; and (4) use solution-focused problem-solving strategy and supportive family communication skills.

Primary outcomes

  1. Change in diabetes control

    Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)

    Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.

  2. Change in diabetes control

    Time frame: Baseline (T1) to six months after intervention (T3) at month 11

    Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.

  3. Change in health-related quality of life

    Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)

    Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.

  4. Change in health-related quality of life

    Time frame: Baseline (T1) to six months after intervention (T3) at month 11

    Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.

Secondary outcomes

  1. Change in blood pressure control

    Time frame: Baseline (T1) to immediate post-intervention at month 5 (T2)

    Change in blood pressure will be measured with average scores of systolic and diastolic pressures.

  2. Change in blood pressure control

    Time frame: Baseline (T1) to six months after intervention (T3) at month 11

    Change in blood pressure will be measured with average scores of systolic and diastolic pressures.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults With Type 2 Diabetes

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.