NCT05343494

Brief Summary

The aim of this project is to use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to collect pilot data on the implementation of a Diabetes Prevention Program-like intervention in the Women, Infants, and Children (WIC) program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

November 30, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 4, 2022

Last Update Submit

November 29, 2022

Conditions

Gestational DiabetesPreDiabetesHyperglycemiaGlucose Intolerance During Pregnancy

Keywords

Diabetes Prevention ProgramBehavioral InterventionDietPhysical ActivitySpecial Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Outcome Measures

Primary Outcomes (1)

  • Fidelity - sessions attended

    Number of sessions attended throughout the 8 week intervention

    8-week intervention

Secondary Outcomes (5)

  • Fidelity - sessions held

    8-week intervention

  • Fidelity - session content

    8-week intervention

  • Intervention feasibility

    2-month data collection visit

  • Intervention appropriateness

    2-month data collection visit

  • Intervention acceptability

    2-month data collection visit

Other Outcomes (11)

  • Diet

    2 months

  • Physical activity

    2 months

  • Weight

    2 months

  • +8 more other outcomes

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

The intervention has been modified from a subset of sessions from the National DPP Prevent T2 Curriculum (an adapted DPP for community settings that improves cardiometabolic outcomes and is implemented nationwide). The intervention will consist of 8 weekly sessions. The first session will be one-on-one and subsequent sessions will be in small groups. Sessions 1, 2, and 6 will be in-person and other sessions will be held by Zoom.

Behavioral: Lifestyle Intervention

Interventions

Lifestyle InterventionBEHAVIORAL

The intervention has been modified from a subset of sessions from the National DPP Prevent T2 Curriculum (an adapted DPP for community settings that improves cardiometabolic outcomes and is implemented nationwide). The intervention will consist of 8 weekly sessions. The first session will be one-on-one and subsequent sessions will be in small groups. Sessions 1, 2, and 6 will be in-person and other sessions will be held by Zoom.

Lifestyle Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • weeks to 12 months postpartum
  • Medical record documented diagnosis of GDM during most recent pregnancy
  • Access to a device that can access the internet
  • English speaking

You may not qualify if:

  • Pregnant or planning to become pregnant in the next two months
  • Planning to move out of the area in the next two months
  • Self-report of diagnosed diabetes
  • Use of glucose-lowering medications
  • Plasma glucose \>200 mg/dL and classic symptoms of hyperglycemia (thirst, polyuria, weight loss, blurry vision) or HbA1c \>6.5% (based on screening visit blood draw)
  • Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane Office of Health Research

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Diabetes, GestationalPrediabetic StateHyperglycemiaMotor Activity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 25, 2022

Study Start

April 4, 2022

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

November 30, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)