Motivational Interviewing With Focus on Diet and Weight Gain in Pregnant Women With Type 2 Diabetes

NCT02883127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 189

Last updated 2021-05-05

No results posted yet for this study

Summary

The primary goal of this case control study is to investigate the effect of implementation of motivational interviewing with focus on diet and weight gain in addition to the routine treatment on prevention of excessive gestational weight gain and fetal growth in pregnant women with type 2 diabetes.

Design: Prospective cohort study where an unselected cohort of all pregnant women with type 2 diabetes are offered intervention with motivational interviewing in addition to routine treatment in the period 2015-2017. For comparison a historical cohort (2013-2015) treated with routine treatment only will be studied. With an inclusion period of 2 years, each cohort is expected to include 150 participants. The women in the study group will receive one-to-one coaching based on the principles of motivational interviewing, every second week throughout the pregnancy. Both cohorts receive the same routine care for pregnant women with type 2 diabetes. An appropriate GWG is targeted. Primary outcome measures are maternal gestational weight gain and the infants Large for Gestational Age.

Conditions

Interventions

BEHAVIORAL

Motivational interviewing

The aim is to provide a one-to-one contact every second week of approximately 10 minutes duration. An action plan for improving dietary behavior will be made during the first session and evaluated in subsequent sessions. The following dietary objectives will be set for each participant to achieve or to maintain: 1. Watch portion size - to be conscious about the amount of carbohydrates in each meal. 2. Eat mainly carbohydrates of low glycaemic index. 3. Reduce the intake of carbohydrate of high glycaemic index. 4. Watch daily weight changes - aim for the recommended weekly changes. In addition to the motivational intervention the women are given unchanged routine care.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Elisabeth R Mathiesen, Professor · Rigshospitalet, Denmark

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2018-02-28
Completion
2019-10-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02883127 on ClinicalTrials.gov