Obesity Clinical Trial
Official title:
Effectiveness of a Normative Intervention (Diet, Physical Activity and Breastfeeding) on Maternal Nutrition and Offspring Growth and Development: Nutrition in the First 1000 Days Key to Healthy Growth and Long-term Health.
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.
Status | Not yet recruiting |
Enrollment | 2400 |
Est. completion date | March 2017 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Pregnant women classified as high risk according to the norms of the Chilean Ministry of Health(MoH) and/or underweight (BMI<18.5) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Chile | Institute of Nutrition and Food Technology | Santiago | Región Metropolitana |
Lead Sponsor | Collaborator |
---|---|
University of Chile | Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, Ministry of Health, Chile, National Nutrition and Food Technology Institute, Pontificia Universidad Catolica de Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight gain and nutritional status in mothers | 36-40 weeks of gestation | Yes | |
Primary | Weight retention | 12 months post-partum | Yes | |
Primary | Glycaemic control | At 20-24 weeks of pregnancy | Yes | |
Primary | Lactation rates | At 12 months post-partum | Yes | |
Primary | Initiation and duration of breastfeeding (exclusive and total) | Birth-12 months | Yes | |
Primary | Weight, length and BMI growth in infants | During the first year of life | Yes | |
Primary | Psychomotor development (based on abbreviated scale) | During the first year of life | Yes | |
Secondary | Implementation | Implementation: compliance to protocol by health personnel, midwives & dieticians per center, time allocated to the actions of the interventions, etc. | At 30 months into the recruitment | Yes |
Secondary | Participant compliance variables | Variables relate to the adoption by participants of the respective program activities: adherence to diet/physical activity prescriptions, adequate referral, attendance to dietician's clinic, lactation workshops, etc. | At 30 months into the recruitment | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |