Lifestyle Interventions to Prevent Diabetes in U.S. Home Visiting Programs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCalifornia Polytechnic State University-San Luis Obispo
About this trial
The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently in home visiting
Pregnant or < 3 months (13 weeks) postpartum
Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report)
Aged 18 years or older
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
GDM Enhanced
BehavioralThe GDM Enhanced intervention is comprised of HV-delivered, evidence-based modules (10-20 minutes) with facilitator guides. The content prioritizes management and prevention of diabetes through healthy eating, physical activity, and stigma-informed weight management strategies.
Meals
BehavioralThe Meal intervention includes medically tailored meals being provided to participants starting after randomization and tailored to their individual dietary preferences and cultural considerations.
Treatment groups
978 Participants
are divided into 2 treatment groupsGroup A: Usual Home Visiting plus GDM EnhancedActive comparator 1 intervention
Group B: Usual HV + GDM Enhanced + MealsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diabetes/Pre-Diabetes
The Primary Outcome Measure in this study is a categorical outcome of glucose tolerance (i.e., healthy glucose tolerance vs. type 2 diabetes/pre-diabetes) at 12 months postpartum. The test will be conducted at CLIA-certified lab. A 2-hour oral glucose tolerance test (OGTT) will characterize people into one of two categories: 1) healthy glucose tolerance; or 2) type 2 diabetes (2-hour post 75g load glucose level of 200 mg/dL or greater) or pre-diabetes (a 2-hour post 75g load glucose level of 140 to 199 mg/d).
Time frame
From enrollment to 12 months postpartumSecondary outcomes
1
HbA1c concentration
HbA1c will be measured utilizing an at-home test kit (finger-stick, whole-blood test)
Time frame
From enrollment to 3, 6, and 12 months postpartum2
Systolic blood pressure
Systolic blood pressure will be self-measured in the home with trained research assistants guiding the assessment
Time frame
From enrollment to 3, 6, and 12 months postpartum3
Diastolic blood pressure
Diastolic blood pressure will be self-measured in the home with trained research assistants guiding the assessment
Time frame
From enrollment to 3, 6, and 12 months postpartum4
Body weight
Body weight is obtained using remote scales provided to participants.
Time frame
From enrollment to 3, 6, and 12 months postpartumOther outcomes
1
Feasibility of Intervention Measure
The Feasibility of Intervention Measure will be used to assess participants' perceptions of how feasible the intervention is to implement. The scale includes 4 items, each rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), resulting in a total score range of 4 to 20. Higher scores indicate greater perceived feasibility of the intervention.
Time frame
12 months postpartum2
Acceptability of Intervention Measure
The Acceptability of Intervention Measure (AIM) will be used to assess participants' perceptions of how acceptable the intervention is. The measure includes 4 items, each rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), resulting in a total score range of 4 to 20. Higher scores indicate greater acceptability of the intervention.
Time frame
12 months postpartum3
Intervention Appropriateness Measure
The Intervention Appropriateness Measure (IAM) will be used to assess participants' perceptions of how suitable the intervention is. The scale consists of 4 items, each rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), yielding a total score range of 4 to 20. Higher scores indicate greater perceived appropriateness of the intervention.
Time frame
12 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
California Polytechnic State University-San Luis Obispo
Lead sponsor
Lifespan/ The Miriam Hospital
Collaborator
Northwestern University
Collaborator
Bradley Hospital
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov