CO-OP Trial: Community-based Outreach on Obesity in Pregnancy

NCT01841424 | Completed DMC

• 1 other identifier: 13-571
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Obesity is becoming more common and disproportionately affects the younger generation, the poor and certain ethnic groups. Nearly 50% of reproductive aged women are obese or overweight. Obesity during pregnancy leads to higher rates of hypertensive disorders, stillbirth, less successful breastfeeding, obesity in their offspring, postpartum depression, and higher weight retention postpartum. Dietary counseling can prevent excessive maternal weight gain and is more effective than activity-based interventions. The two objectives of this study are 1) to use community-based techniques to improve dietary counseling for high risk women and 2) to randomize obese women to dietary counseling at Truman Medical Center and measure their success. The hypothesis is that dietary interventions can successfully be tailored for high risk women and that excessive weight gain during pregnancy can be avoided.

Conditions

Obesity; Pregnancy

Keywords

dietary counseling; food diary; obesity; pregnancy; weight gain

Outcome Measures

Primary Outcomes (1)

• Dietary intervention to prevent excessive maternal weight gain during pregnancy

  Primary outcome 1\. Does the optimized dietary intervention for obese, urban and under-resourced women prevent excessive maternal weight gain as measured in kilograms from enrollment prior to 16 weeks to the final measurement before delivery?

  12-18 months

Secondary Outcomes (11)

• Difference in complication rates between study and control group

  12-18 months

• Differences between birth weights in the study and control groups

  12-18 months

• Differences in leptin levels between study and control groups

  12-18 months

• Difference in food frequency questionnaire responses between study and control groups

  18-24 months

• Is infant birth weight correlated with total gestational weight gain?

  12-18 months

Study Arms (2)

Control

NO INTERVENTION

Subjects receive usual care for pregnancy and postpartum.

Dietary Counseling and Food Diary

EXPERIMENTAL

Dietary counseling before 16 weeks of pregnancy Maintain food diary during pregnancy

Behavioral: Dietary counseling. Maintain a food diary.

Interventions

Dietary counseling. Maintain a food diary. BEHAVIORAL

The dietary intervention will be conducted by a registered dietician once. The dietary guidelines for study participants will be similar to those for gestational diabetes including 18 to 24 kcal/kg diet with 40% carbohydrates, 30% protein, 30% fat. No participant will be given a diet that is less than 2,000 kcal per day. Study subjects will record a food diary and to bring it to prenatal visits. Study subjects will limit intake of high calorie dense and acellular processed foods to 1-2 times per week if at all and to increase total percentage of fruits and vegetables to 5-9 items per day.

Also known as: diet, advice, instruction, dietition, nutrition, nutritional, food log

Dietary Counseling and Food Diary

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Less than 16 weeks pregnant
• Obese (defined as BMI \>30)
• Willing to participate in the study

You may not qualify if:

• Multiples (twins, triplets, etc.)
• Abnormal 1 hour glucola prior to 16 weeks of pregnancy
• Pregestational diabetes
• Stillbirth or miscarriage prior to 20 weeks of pregnancy

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• Truman Medical Center: collaborator

Study Sites (2)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64114, United States

Location

Related Links

• University of Missouri Kansas City

MeSH Terms

Conditions

Obesity; Weight Gain

Interventions

Diet; Counseling; Educational Status; Nutritional Status

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Health Status; Demography

Study Officials

• Teresa A Orth, MD, PhD

  UMKC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 26, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (2)