NCT01916603

Brief Summary

NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions in both mother and offspring. Weight gain during the first two years of life is also critical in defining the infant's predisposition to obesity during adulthood. Objective: to assess the effectiveness of delivering a primary health care intervention to enhance compliance with updated nutrition and health care (diet, physical activity and breastfeeding) standards from early pregnancy through the first year of life. Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention "program effectiveness" study (i.e. intervention will be available through the established national health system under standard operating conditions). A cluster unit will be a primary health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to: enhanced nutrition and health care (intervention group) or routine nutrition and health care (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we will complete 960 women per arm. After randomization, pregnant women in the intervention PHCCs starting at their first pre-natal visit (\< 15 wks.) will receive, diet and physical activity (PA) counseling-support based on updated recommendations and monitoring goals for weight gain \& glycemic control and breastfeeding (BF) promotion till 12 m postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care according to national guidelines. Expected results: participants in the intervention PHCCs will benefit by achieving adequate nutritional status \& metabolic control, during and early after, pregnancy as well as adequate infant growth \& development as a result of improved nutrition and health care practices. The results will likely be generalizable through the primary health care system; considering this is a "program effectiveness" trial conducted under "real life" conditions . Additionally, we will include specific ancillary mechanistic projects to better characterize the intervention and its impact.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

July 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 5, 2013

Status Verified

July 1, 2013

Enrollment Period

Same day

First QC Date

July 4, 2013

Last Update Submit

August 1, 2013

Conditions

ObesityWeight GainMetabolic DiseasesBirth WeightInfant Nutrition Disorders

Outcome Measures

Primary Outcomes (7)

  • Weight gain and nutritional status in mothers

    36-40 weeks of gestation

  • Weight retention

    12 months post-partum

  • Glycaemic control

    At 20-24 weeks of pregnancy

  • Lactation rates

    At 12 months post-partum

  • Initiation and duration of breastfeeding (exclusive and total)

    Birth-12 months

  • Weight, length and BMI growth in infants

    During the first year of life

  • Psychomotor development (based on abbreviated scale)

    During the first year of life

Secondary Outcomes (2)

  • Implementation

    At 30 months into the recruitment

  • Participant compliance variables

    At 30 months into the recruitment

Study Arms (2)

Normative intervention

EXPERIMENTAL

Normative intervention on diet \& physical \& breastfeeding: diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum

Behavioral: Normative Intervention

Routine care

NO INTERVENTION

Routine antenatal care according to national guidelines

Interventions

Normative InterventionBEHAVIORAL

Diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum

Normative intervention

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women seeking care before 15 weeks of pregnancy, residents within catchment area of selected Primary Health Care Centers, who are not planning to move in the next two years will be invited to participate in the study

You may not qualify if:

  • Pregnant women classified as high risk according to the norms of the Chilean Ministry of Health(MoH) and/or underweight (BMI\<18.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition and Food Technology

Santiago, Santiago Metropolitan, 7830490, Chile

Location

Related Publications (4)

  • Mujica-Coopman MF, Corvalan C, Flores M, Garmendia ML. The Chilean Maternal-Infant Cohort Study-II in the COVID-19 Era: A Study Protocol. Front Public Health. 2022 Jul 14;10:904668. doi: 10.3389/fpubh.2022.904668. eCollection 2022.

    PMID: 35910889DERIVED

  • Garmendia ML, Corvalan C, Araya M, Casanello P, Kusanovic JP, Uauy R. Effectiveness of a normative nutrition intervention in Chilean pregnant women on maternal and neonatal outcomes: the CHiMINCs study. Am J Clin Nutr. 2020 Oct 1;112(4):991-1001. doi: 10.1093/ajcn/nqaa185.

    PMID: 32692805DERIVED

  • Garmendia ML, Mondschein S, Matus O, Murrugarra R, Uauy R. Predictors of gestational weight gain among Chilean pregnant women: The Chilean Maternal and Infant Nutrition Cohort study. Health Care Women Int. 2017 Aug;38(8):892-904. doi: 10.1080/07399332.2017.1332627. Epub 2017 May 19.

    PMID: 28524735DERIVED

  • Garmendia ML, Corvalan C, Araya M, Casanello P, Kusanovic JP, Uauy R. Effectiveness of a normative nutrition intervention (diet, physical activity and breastfeeding) on maternal nutrition and offspring growth: the Chilean maternal and infant nutrition cohort study (CHiMINCs). BMC Pregnancy Childbirth. 2015 Aug 18;15:175. doi: 10.1186/s12884-015-0605-1.

    PMID: 26283529DERIVED

MeSH Terms

Conditions

ObesityWeight GainMetabolic DiseasesBirth WeightInfant Nutrition Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Ricardo Uauy, PhD

    University of Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria L Garmendia, PhD

CONTACT

56229781402mgarmendia@inta.uchile.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Doctor in Philosophy

Study Record Dates

First Submitted

July 4, 2013

First Posted

August 5, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2013

Study Completion

March 1, 2017

Last Updated

August 5, 2013

Record last verified: 2013-07

Locations

CL(1)