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Behavioural Intervention

Health Coaching Strategies for Preventing Postpartum Diabetes (STRIVE Trial)

N/A

Recruiting

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No self-reported diabetes (other than gestational diabetes)

Age 18 or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 3, 6, 9 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two approaches to help postpartum women prevent diabetes, one with in-person health coaching and the other with tech-assisted health coaching.

Who is the study for?

This trial is for postpartum women who are 18 or older, gave birth within the last year, and have obesity or a history of gestational diabetes. They should not currently have diabetes (except gestational), plan to become pregnant soon, or move away in the next year. Access to a smartphone is required.

What is being tested?

The STRIVE study compares two ways of delivering a Diabetes Prevention Program: one with an in-person health coach at WIC clinics and another combining in-person sessions with technology support like apps.

What are the potential side effects?

Since this trial involves lifestyle interventions rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but will vary based on individual experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have diabetes, except for gestational diabetes if applicable.

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I am 18 years old or older.

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I am obese or have had gestational diabetes with a current BMI of 25 or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 3, 6, 9 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 3, 6, 9 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 3, 6, 9 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in mean 12-month weight reduction (primary health-related outcome)

Difference in uptake (primary implementation outcome)

Secondary study objectives

Acceptability

Adoption (WIC clinics)

Adoption (WIC health educators)

+18 more

Other study objectives

Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff

Sustainability (Participants): comparison of the proportion of participants maintaining DPP goals at six months after their participation in the DPP has ended

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: In-person health coach strategyActive Control1 Intervention

Delivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.

Group II: Multifaceted technology-assisted health coach implementation strategyActive Control1 Intervention

Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.

0 / 3Eligibility criteria met