Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women

Gestational Diabetes Prevention Program

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02763150

Enrollment

199

Registered

2016-05-05

Start date

2017-12-15

Completion date

2022-07-29

Last updated

2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes Prevention

Brief summary

The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.

Interventions

BEHAVIORALLifestyle intervention

Intervention group will receive comprehensive behavioral weight loss program.

OTHERHealth Promotion

The health promotion group will receive education on healthy eating and activity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Prior diagnosis of gestational diabetes. * BMI \> 25 kg/m2 * Planning to have a baby in the next 1-3 years * English or Spanish speaking

Exclusion criteria

* Age less than 18 years * Women with Type 2 or Type 1 diabetes * Current pregnancy * Relocating in the next 2 years * Medications that affect weight/diabetes * Serious current physical disease * History of eating disorders * History of bariatric surgery * Current problems with drug abuse * Current treatment of a serious psychological disorder

Design outcomes

Primary

Measure	Time frame
Incidence of Gestational Diabetes Mellitus	26 weeks gestation

Secondary

Measure	Time frame
Changes in maternal levels of fasting insulin	study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of systolic and diastolic blood pressure	study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of C-reactive protein	study entry, 16 weeks, 26 weeks gestation
Incidence of preeclampsia	Delivery
Changes in maternal levels of fasting glucose	study entry, 16 weeks, 26 weeks gestation
Weight changes	study entry, 16 weeks, 26 weeks gestation
Daily caloric intake	study entry, 16 weeks, 26 weeks gestation
Minutes per week of moderate physical activity	study entry, 16 weeks, 26 weeks gestation
Incidence of cesarean delivery	Delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026