Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes

NCT01681147 | Completed Results

• 1 other identifier: CHS 2012-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether women who have had gestational diabetes mellitus (GDM) will make healthier lifestyle choices, achieve weight goals, and complete postpartum care assessments after receiving two online classes on healthy nutrition and exercise classes at 6 weeks - 3 months and at 9 months postpartum.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes; postpartum; nutrition; exercise

Outcome Measures

Primary Outcomes (3)

• Weight Loss

  1\. Postpartum weight loss (target 7% less than the pre-pregnancy weight for overweight/obese women and back to pre-pregnancy weight for normal BMI women). This will be based on medical record information on pre-pregnancy weight and self-reported or health-care provider reported weight at 12 months.

  1 year postpartum

• Postpartum Diabetes Screening at One Year

  1. Adherence to diabetes screening using the 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose at 12 months (+/- 3 months). 2. Lab results from the fasting glucose test or results from a 75 gram 2 hour OGTT at 12 months among women who choose to take the diabetes screening test.

  1 year postpartum

• Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals

  2\. Determine to what extent barriers to health impact adherence rates to post partum screening and weight loss targets through a web-based questionnaire collected on the 6 weeks to 3 months, 6, 9, and 12 month questionnaires. These questionnaires will assess whether: lack of self care, perception of high infant care giving needs, fear of diabetes diagnosis and postpartum depressive symptoms, difficulty accessing medical care, dissatisfaction with medical care or primary care physician not recommending screening are associated with poorer adherence to diabetes screening guidelines and weight loss goals.

  Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported

Secondary Outcomes (3)

• Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum

  3 months, 6 months, 9 months, all reported

• Food Frequency Questionnaire

  3 months, 6 months, 9 months, all reported

• Exercise Frequency in Women With Gestational Diabetes Post-Partum

  3 months, 6 months, 9 months, all reported

Study Arms (3)

Standard Care

NO INTERVENTION

Standard postpartum care after a pregnancy with gestational diabetes

Standard Care+Education Classes

EXPERIMENTAL

Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes

Behavioral: 2 online nutrition and exercise education classes

Standard Care+Education Classes+Glucose Monitoring

EXPERIMENTAL

Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes Self monitoring of blood glucose levels

Behavioral: 2 online nutrition and exercise education classes; Behavioral: Self monitoring of blood glucose levels

Interventions

2 online nutrition and exercise education classes BEHAVIORAL

Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months

Standard Care+Education Classes; Standard Care+Education Classes+Glucose Monitoring

Self monitoring of blood glucose levels BEHAVIORAL

Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum

Standard Care+Education Classes+Glucose Monitoring

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational Diabetes
• Age between 21 and 45 years
• Preconception BMI 19-40
• Seen for at least 2 visits in the Diabetes in Pregnancy Program during their pregnancy
• Singleton pregnancy

You may not qualify if:

• Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram 2 hour OGTT
• BMI \>40
• Multiple gestation (i.e., twins, triplets, etc.)

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Limitations and Caveats

Difficulty enrolling and retaining patients for the study; high survey completion but lack of online intervention education modules completion; lack of patient follow up with primary care provider for weights and glucose 1yr postpartum; pilot study.

Results Point of Contact

• Title: Dr. Florence Brown
• Organization: Joslin Diabetes Center

Florence.Brown@joslin.harvard.edu

617-309-2675

Study Officials

• Florence Brown, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: June 1, 2012
• Primary Completion: January 20, 2018
• Study Completion: September 10, 2018
• Last Updated: May 12, 2023
• Results First Posted: May 12, 2023

Record last verified: 2022-07

Locations

US (1)