Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial

NCT00792480 | Terminated DMC

• 1 other identifier: WIP 06-05-04A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.

Conditions

Obesity; Pregnancy

Keywords

Obesity; Pregnancy; Exercise; Nutrition; obesity in pregnancy

Outcome Measures

Primary Outcomes (1)

• The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.

  3 - 6 months

Secondary Outcomes (1)

• The investigators secondary outcomes will include the effect of weight gain on mode of delivery, rate of operative vaginal delivery, infant weight, and the incidence of preeclampsia, GDM, vaginal/perineal lacerations, and shoulder dystocia.

  3 - 6 months

Study Arms (2)

Intensive Counseling Group

EXPERIMENTAL

Behavioral: Dietary and lifestyle counseling

Routine care group

NO INTERVENTION

The routine care group took part in an initial physical exam and history, routine labs, and routine visits per American College of Obstetrics \& Gynecology (ACOG) standards. The only counseling on diet and exercise during pregnancy was that included in our standard prenatal booklet "What to do When You're Having a Baby" by Gloria Mayer (Institute for Health Advancement, 2003, La Habra, CA). At each routine obstetric appointment, the participant's weight was measured recorded in the medical chart. The healthcare provider did not counsel the participant regarding any changes in diet or lifestyle.

Interventions

Dietary and lifestyle counseling BEHAVIORAL

The intervention group will undergo a complete history and physical with attention to prepregnancy weight, current weight, height, and BMI. At the initial visit, they will meet with a registered dietician to receive a standardized counseling session, including information on pregnancy-specific dietary and lifestyle choices. The patient will be instructed to engage in moderate intensity exercise at least 3 times per week and preferably 5 times per week. They will also receive information on the appropriate weight gain during pregnancy using the IOM guidelines. Each subject will meet with the dietician only at the time of enrollment. At each routine obstetric appointment, the participant's weight will be measured and charted on an IOM Gestational Weight Gain Grid in front of the participant. The healthcare provider will inform the participant if her weight gain was at the appropriate level and counsel her accordingly regarding increasing or decreasing her intake and exercise.

Intensive Counseling Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Establish prenatal care at 6 - 16 weeks gestation
• years of age
• Receive their entire prenatal care at the Resident Obstetrics Clinic
• English and/or Spanish speaking
• Singleton gestation.

You may not qualify if:

• Establish prenatal care \>16 weeks gestation
• Non-English or non-Spanish speaking
• Multiple gestation pregnancy
• BMI \> 40
• Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
• Delivery at institution other than CMC-Main
• Pregnancy ending in a premature delivery (\< 37 weeks)
• Limited prenatal care (\<4 visits)

Sponsors & Collaborators

• Carolinas Medical Center: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

• Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):305-12. doi: 10.1097/AOG.0b013e318195baef.

  PMID: 19155899 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Pregnancy in Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shelly M Asbee, M.D.

  Lake Norman Ob/Gyn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 18, 2008
• Study Start: October 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: November 18, 2008

Record last verified: 2008-11

Locations

US (1)