Conditional Cash Transfer Intervention to Improve T2DM

NCT05559892 | Active Not Recruiting DMC

• 1 other identifier: 1K01DK131319
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Glycemic control (HbA1c)

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

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

• Quality of Life as measured by SF-12

  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.

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

Secondary Outcomes (1)

• Self-Care

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

Study Arms (2)

Diabetes-Tailored CCTs (DM-CCT) Intervention

EXPERIMENTAL

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). Therefore, they will only receive cash transfer payments if they attend two sessions per month.

Behavioral: DM-CCT

Unconditional Cash Transfer-UCTs Intervention

ACTIVE COMPARATOR

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.

Behavioral: DM-UCT

Interventions

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).

Diabetes-Tailored CCTs (DM-CCT) Intervention

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.

Unconditional Cash Transfer-UCTs Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

State University at Buffalo

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jennifer A Campbell, PhD

  State University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)