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Trial record 18 of 92 for:    "social work" | Open Studies

Mood and Excess Weight Gain in Adolescent Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Colorado State University
Sponsor:
Collaborators:
University of Colorado, Denver
Children's Hospital Colorado
Information provided by (Responsible Party):
Colorado State University
ClinicalTrials.gov Identifier:
NCT03086161
First received: March 9, 2017
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.

Condition Intervention
Obesity
Adolescent Development
Pregnancy Related
Insulin Sensitivity
Interpersonal Relations
Stress
Behavioral: Interpersonal Psychotherapy for the Prevention of Excess Gestational Weight Gain
Behavioral: Treatment-as-usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Care Provider
Masking Description:
Care providers delivering usual prenatal care are unaware of condition assignment.
Primary Purpose: Prevention
Official Title: Mood and Excess Weight Gain in Adolescent Pregnancy

Resource links provided by NLM:


Further study details as provided by Colorado State University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 5-year period ]
    Rate of recruitment

  • Acceptability [ Time Frame: 6-9 months ]
    Program session attendance measured as percentage of total sessions (6) attended

  • Acceptability of program [ Time Frame: 6-9 months ]
    Program acceptability ratings


Secondary Outcome Measures:
  • Depressive symptoms [ Time Frame: 12 months (9 months of pregnancy plus 3 months postpartum) ]
    Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale

  • Perceived stress [ Time Frame: 12 months (9 months of pregnancy plus 3 months postpartum) ]
    Perceived stress measured on the Perceived Stress Scale

  • Excess gestational weight gain [ Time Frame: 9 months ]
    Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery

  • Maternal postpartum insulin sensitivity [ Time Frame: 12 months (9 months of pregnancy plus 3 months postpartum) ]
    Maternal postpartum insulin sensitivity

  • Maternal postpartum adiposity [ Time Frame: 12 months (9 months of pregnancy plus 3 months postpartum) ]
    Maternal postpartum body fat percentage

  • Infant adiposity [ Time Frame: Infants: 3 months ]
    Infant body fat percentage


Estimated Enrollment: 50
Actual Study Start Date: November 23, 2015
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment-as-usual
Treatment-as-usual alone provided in the context of a multi-disciplinary teen pregnancy clinic providing wrap-around medical, nutrition, and social work care.
Behavioral: Treatment-as-usual
Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work
Experimental: Interpersonal Psychotherapy
Treatment-as-usual plus a six-session interpersonal psychotherapy program delivered as individual sessions by a trained facilitator every 2-3 weeks throughout pregnancy.
Behavioral: Interpersonal Psychotherapy for the Prevention of Excess Gestational Weight Gain
Six individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy
Behavioral: Treatment-as-usual
Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work

Detailed Description:
Obesity and its negative health consequences such as type 2 diabetes and heart disease are major public health concerns. Pregnancy is an ideal opportunity to intervene with young women both to reduce their own likelihood of long-term obesity and to potentially lessen their offspring's obesity risk. Interventions to reduce excessive weight gain during adolescent pregnancy may be particularly important. 50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. Depression and stress-which are common in adolescent pregnancy-also may play a role. Pregnant adolescent females, as well as non-pregnant females, who have more frequent feelings of depression or stress are more likely to gain weight too rapidly or to gain too much weight as they grow. In the current project, the investigators seek to develop a program to prevent excess weight gain that will be feasible to administer in the Colorado Adolescent Maternity Program (CAMP) at Children's Hospital Colorado, University of Colorado Denver, Anschutz Medical Campus, and, that will be acceptable to pregnant teens at-risk for gaining too much weight. After a screening assessment, adolescent females (13-19y) will be randomly assigned to participate in either a 6-session interpersonal psychotherapy (IPT) program + usual care or to CAMP usual care only. The IPT program will involve 6 1-hour meetings with a trained facilitator and focus on improving relationships, mood, stress, and eating in response to negative feelings. The investigators will assess participants midway through the program, immediately after the program, and again at a 3-month postpartum follow-up. The investigators will evaluate to what extent adolescent females attend the program, complete at-home practice assignments, and show changes in mood, stress, relationships, eating, and mindfulness before and after IPT participation compared to usual care only. The investigators also will estimate how program participation relates to weight gain during pregnancy and 3-month postpartum maternal weight retention, adiposity, and insulin sensitivity. The investigators also will study the adiposity of adolescents' 3-month-old infants.
  Eligibility

Ages Eligible for Study:   3 Months to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-19 years of age and the 3-6 month old infants of these adolescent mothers
  • Female
  • Pregnant, 12-18 weeks gestation
  • Patient in the Colorado Adolescent Maternity Program (CAMP) clinic

Exclusion Criteria:

  • Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)
  • Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder
  • Medication affecting mood or body weight
  • Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)
  • Pre-pregnancy BMI <5th percentile for age and sex
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03086161

Contacts
Contact: Lauren B Shomaker, PhD (970)49103217 lauren.shomaker@colostate.edu

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Lauren Shomaker, PhD    970-491-3217    lauren.shomaker@colostate.edu   
Sponsors and Collaborators
Colorado State University
University of Colorado, Denver
Children's Hospital Colorado
Investigators
Principal Investigator: Lauren B Shomaker, PhD Colorado State University
  More Information

Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT03086161     History of Changes
Other Study ID Numbers: 14-1505
Study First Received: March 9, 2017
Last Updated: March 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Insulin Resistance
Weight Gain
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017