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Active, Not Recruiting

NCT Number: NCT05559892

Conditional Cash Transfer Intervention to Improve T2DM

This study will test the preliminary efficacy of diabetes-tailored CCT (DM-CCT), which will be conditional on participating in biweekly (every two weeks), nurse-led, virtual diabetes education/skills training and stress/coping intervention compared to UCT (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in 100 inner city AAs with poorly controlled T2DM using an RCT design. The aims of the proposed study include:

AIM 1: Test the preliminary efficacy of the DM-CCT intervention on glycemic control and quality of life for inner-city AAs with T2DM.

AIM 2: Test the preliminary efficacy of the DM-CCT intervention on self-care behaviors and psychological health for inner-city AAs with T2DM.

AIM 3: Estimate the cost of delivery of the DM-CCT and UCT interventions in preparation for future cost effectiveness analysis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University at Buffalo

Buffalo, New York, 14203, United States

About this study

The overarching aim of this proposal is to test the preliminary efficacy of diabetes-tailored CCT (DM-CCT conditional on participating in biweekly, nurse-led, virtual diabetes education/skills training and stress/coping intervention) compared to UCT (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in inner city African Americans with poorly controlled T2DM. One hundred (100) individuals will be randomized to either the DM-CCT intervention or the UCT intervention and followed for 6-months, with study visits at baseline, 3-months, and 6-months. The primary outcomes will be glycemic control (HbA1c) and quality of life (SF-12) at 6-months post randomization. The secondary outcomes will be self-care behaviors (diet, exercise, medication adherence) and psychological health (stress, coping) measured at 6-months post randomization. In preparation for future cost effectiveness studies, the final aim will estimate the cost of delivery of the DM-CCT and UCT interventions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥18 years
  • Self-report as African American
  • Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
  • Residence in inner city zip codes
  • Income greater or equal to133% of federal poverty level or Medicaid eligible
  • Able to communicate in English.

Exclusion criteria

  • Mental confusion on interview suggesting significant dementia
  • Alcohol or drug abuse/dependency
  • Active psychosis or acute mental disorder
  • Participation in other diabetes clinical trials
  • Life expectancy <6 months

Treatment and study plan

DM-CCT

Behavioral

Participants randomized to DM-CCT will receive cash transfers of $500 per month for 6 months, but the cash transfers will be conditional on attending a 60-minute diabetes education/skills training (30 minutes) and stress/coping (30 minutes) session delivered by trained nurses every 2 weeks for 6 months (12 sessions).

DM-UCT

Behavioral

Participants randomized to UCT will receive cash transfers of $500 per month for 6 months, but there will be no conditions attached. Therefore, they will receive cash transfer payments every month. However, to control for content and attention, participants will receive mailed version of the diabetes education/skills training materials every two weeks on the same schedule as the DM-CCT telephone sessions.

Primary outcomes

  1. Glycemic control (HbA1c)

    Time frame: Change from baseline HbA1c at 6 months post intervention follow-ups

    Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.

  2. Quality of Life as measured by SF-12

    Time frame: Change from baseline quality of life measure at 6 months post intervention follow-ups

    The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.

Secondary outcomes

  1. Self-Care

    Time frame: Change from baseline self-care at 6 months post intervention follow-ups

    Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Conditional Cash Transfer Intervention to Improve Health Outcomes Among Inner-City African Americans With T2DM

Acronym: DMCT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2022
Registry last updated
Oct 1, 2025

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.

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