NCT01628835

Brief Summary

The study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the Chinese Dietary Guide for Pregnant Women on maternal and neonatal insulin resistance and adverse gestational events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

May 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

3.7 years

First QC Date

May 10, 2012

Last Update Submit

August 23, 2016

Conditions

OverweightPregnant Women

Keywords

overweightpregnancydiet counsellingglycemic

Outcome Measures

Primary Outcomes (5)

  • Maternal insulin resistance

    During pregnancy

  • Cord blood C-peptide

    at delivery

  • Maternal weight gain

    measured before delivery (minus pre-conceptual body weight)

    measured before delivery

  • Incidence of gestational diabetes

    from 1st antenatal visit to delivery

    during pregnancy

  • Incidence of macrosomia

    birth weight \>= 4000g

    at delivery

Secondary Outcomes (6)

  • Incidence of gestational hypertension

    during pregnancy

  • Mean infant birth weight

    at delivery

  • cesarean

    at delivery

  • head circumference

    at delivery

  • Mean gestational age

    at delivery

  • +1 more secondary outcomes

Study Arms (2)

Low dietary glycemic index diet

EXPERIMENTAL

Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided.

Behavioral: Low dietary glycemic index diet

National recommendation diet

ACTIVE COMPARATOR

Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information

Behavioral: National recommendation diet

Interventions

Low dietary glycemic index dietBEHAVIORAL

Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided

Low dietary glycemic index diet
National recommendation dietBEHAVIORAL

Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information

Also known as: recommended diet for pregnant women
National recommendation diet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy;
  • Pregnant women with BMI≥24 kg/m2 at first antenatal examination;
  • aged 18 years to 45 years;
  • The week of first prenatal examination equal to or less than 12 weeks;
  • Take routine prenatal examination;
  • Artificial impregnation;
  • History of hypertension, diabetes, coronary heart disease or mental disorder;
  • With Special diet habit(e.g. vegetarianism/ veganism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kunshan Maternal and Child Health Care Hospital

Kunshan, Jiangsu, China

Location

International Peace Maternity and Child Care Centers of Communications University

Shanghai, 201102, China

Location

Related Publications (1)

  • Zhang Y, Wang L, Yang W, Niu D, Li C, Wang L, Gu P, Xia Y, Shen Y, Yan J, Zhao Q, Mu K, Yan W. Effectiveness of Low Glycemic Index Diet Consultations Through a Diet Glycemic Assessment App Tool on Maternal and Neonatal Insulin Resistance: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 18;7(4):e12081. doi: 10.2196/12081.

    PMID: 30998227DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director

Study Record Dates

First Submitted

May 10, 2012

First Posted

June 27, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

CN(2)