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Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers

NCT03781102 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-08-19

No results posted yet for this study

Summary

The two main questions that this research study will answer:

1. will a 16-week community-based diabetes prevention program for delivery to at-risk mothers and children in a Federally Qualified Health Center (FQHC) setting show (a) pre- and post-intervention improvements to Type 2 Diabetes risk factors in 60 mother-child dyads; (b) intervention vs. control improvements to T2D risk factors in 30 mother-child dyads; and (c) maintenance effects to changes to Type 2 Diabetes risk factors in 30 mother-child dyads; and
2. based on the acceptability, adoption, relevance to FQHC and participants, feasibility, fidelity, program costs, and factors influencing sustainability of this program, can it be disseminated nationwide to other FQHC's?

The investigators hypothesize that participants (a) will show improvements following the intervention to T2D risk factors, (b) in the intervention will show significant improvements to T2D risk factors in versus the controls, and (c) will maintain the benefits beyond the 16-week intervention. The investigators also predict that this program will meet criteria to be disseminated nationwide to other FQHC's.

Conditions

Interventions

BEHAVIORAL

16-Week Diabetes Prevention Program for Mothers and Children

The 16-week intervention is focused on ways to modify behaviors associated with the pathogenesis of Type 2 Diabetes in youth, while engaging participants in fun, active, and interactive food demonstrations, energy balance, and physical activities appropriate for all the family. Weekly sessions will consist of: (1) physical activity upon arrival; (2) small group discussions; (3) hands-on food preparation and tasting opportunities; (4) low- to no-cost fun family physical activities; (5) energy balance activities (e.g. label reading) to increase foundational knowledge; and, (6) opportunities to set new weekly goals.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Melanie D Hingle, PhD · University of Arizona

  • David G Marrero, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-03-13
Completion
2020-03-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781102 on ClinicalTrials.gov