Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01081340
Other study ID # IRB00034677
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2010
Est. completion date August 2011

Study information

Verified date August 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine whether we can use social networks to spread health information and health behaviors that 1) support women in returning to their pre-pregnancy weight after delivery; and 2) promote healthy infant feeding practices.


Description:

The long-term goal of this research is to prevent obesity-related adverse health outcomes for future generations by applying information emerging from social network studies to the development of new population-based behavioral interventions. There are a number of critical periods during fetal and infant development that appear to influence the later development of obesity. Interventions that prevent insult to these critical windows from occurring could improve children's life course trajectories. This project sets the groundwork for examining whether social networks could explicitly be utilized to prevent obesity from developing by transmitting health information and health behaviors that 1) prevent postpartum weight retention in first time mothers and 2) promote appropriate infant feeding practices. The secondary aim is to assess which individual-level network-related characteristics best predict postpartum body composition and infant feeding practices.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Latina (self-defined, or born in Central or South America)

- Spanish-speaking and/or English-speaking,

- 18 years of age or older

- less than 24 weeks pregnant

- did or did not have a termination of a previous pregnancy before 20 weeks

- has not carried a pregnancy to term

- normal, overweight or obese (pre-pregnancy BMI >18.5 and <39)

Exclusion Criteria:

- non-Latina,

- non-Spanish-speaking or non-English speaking

- less than 18 years of age

- more than 24 weeks pregnant

- had a termination of a previous pregnancy after 20 weeks

- multiparous

- underweight (pre-pregnancy BMI < 18.5)

- morbidly obese (pre-pregnancy BMI = 39)

- currently enrolled in another program that targets weight, physical activity, or nutrition

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social network building intervention
Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum
Home visit
Three home visits during third trimester and three during postpartum period until 6 months postpartum

Locations

Country Name City State
United States Coleman Regional Community Center - Parks & Rec Department Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight (kg) gestational weight gain and postpartum weight loss 6 times over 10 months
Secondary Body composition BIA postpartum 3 times over 6 months
Secondary Infant feeding practices duration of breastfeeding, use of supplemental fluids, overfeeding, timing of the introduction of solids 3 times over 6 months
Secondary Social network structure number and type of relationships 6 times over 10 months
Secondary Waist Circumference 3 times over 6 months
Secondary Depression 6 times over 10 months
Secondary Nutrition Fat/Fruit/Vegetable intake 6 times over 10 months
Secondary Physical Activity self-report 6 times over 10 months
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) 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