Overweight Clinical Trial
Official title:
Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
Verified date | August 16, 2016 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine whether family-based interpersonal psychotherapy (FB-IPT) is an
effective tool for helping pre-adolescent girls and boys at risk for become obese to reduce
weight gain. IPT is a time-limited group therapy for preventing and treating depression in
children. It is also effective for treating binge eating disorder in adults and has resulted
in weight maintenance or modest weight loss in obese adults. IPT focuses on improving how
people relate to one another by relating symptoms to personal problem areas and then
developing strategies for dealing with these problems. Girls and boys between the ages of
8-13 years of age who are in good general health with the exception of being overweight and
whose body mass index (BMI) is above the 85th percentile for their age and sex may be
eligible for this study. Candidates are screened with a physical examination, measurement of
their height and weight, blood and urine tests, a DEXA scan (x-ray scan that measures body
fat, muscle and bone mineral content), and questionnaires and an interview to obtain
information about the child's general health, social and psychological function, and eating
patterns. Parents are also screened for their health and are asked to give blood samples for
genetic studies and participate in a few questionnaires and interviews.
Participants are randomly assigned to participate in FB-IPT or a health education program.
Both programs involve 12 weekly visits. At the end of the study, the body weight and mood of
the girls and boys in both groups are compared.
Participants (a parent and their child) meet individually with the therapist for 12 sessions
(each approximately an 45 minutes ). Girls and boys offered FB-IPT have meetings in which
they develop strategies for dealing with the problems girls struggle with that may lead to
increased eating. Girls and boys in the health education group have meetings that focus on
teaching teens children to live healthier lives and review topics related to developing and
maintaining healthy eating and exercise.
All participants are evaluated at the end of the 12-week program and asked to return to the
NIH for follow-up visits at post treatment, 6 and 12 months following initiation of the
program.
Each child and parent will be compensated for their time and inconvenience with $40 for
completing all pre-program assessments, $40 for attending the 12 week follow-up visit, $40
for the 6 month follow-up visit, and $40 for the 1-year follow-up. Therefore, each child may
receive up to $160, and the participating parent may receive up to $160. If a child's second
biological parent is also willing to give a genetic sample and undergo interviews, the second
parent can also receive $40 for a single visit to the NIH.
Status | Completed |
Enrollment | 147 |
Est. completion date | August 16, 2016 |
Est. primary completion date | August 16, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 13 Years |
Eligibility |
- INCLUSION CRITERIA: Volunteers will qualify if they meet the following criteria: - Good general health. A normal history and physical examination with the exception of overweight will be required. - Age greater than or equal to 12 and < 18 years at the start of the study. - Female. - Body mass index measured at the NIH is within the 75th 97th percentile for age, gender, and race. - English speaking. - Ability to complete study procedures including the ability to participate in a group. Individuals will be individually assessed to determine their suitability for group treatment. School placement (e.g. special education) will be used as an estimate of cognitive functioning. - As assessed by the Eating Disorder Examination structured clinical interview (see methods), a history of LOC eating (objective or subjective bulimic episodes, or both) or no reports of LOC eating. EXCLUSION CRITERIA: Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons: - Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Nonserious medical illnesses, such as seasonal allergies, will be reviewed on a case-bycase basis. - Presence of an obesity-related medical complication that would require a more aggressive weight loss intervention approach. Such comorbidities include hyperlipidemia (LDL-cholesterol > 130 mg/dL), hypertension (defined by age- sexand height- specific standards (115) fasting hyperglycemia (fasting glucose > 126 mg/dL) and nonalcoholic steatohepatitis (ALT above NIH Clinical Center laboratory norms with consistent radiologic findings and absence of another cause such as infectious hepatitis). - Regular use of prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. Individuals taking medications for most conditions will be excluded, but medication use for non-serious conditions (e.g., acne) will be considered on a caseby- case basis. In particular, participants currently prescribed SSRI s, neuroleptics, tricyclics, stimulants, or any medication known to affect body weight or eating will be excluded. - Current involvement in psychotherapy or a structured weight loss program, - Weight loss during the past 2 months for any reason exceeding 3% of body weight. - Pregnant or recently pregnant girls (within 1 year of delivery). - History of an eating disorder or a current eating disorder (other than binge eating disorder) as determined by medical history or if uncovered during the study s structured clinical interviews. Subjects found to have an eating disorder other than binge eating disorder at baseline will be referred to mental health specialists for further evaluation and treatment. - Current pregnancy or breast feeding. A negative pregnancy test before starting the study will be required. Because pregnancy is a state in which weight gain is expected and appropriate, pregnant individuals would not be suitable for this study. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives ( the pill ), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended. - Individuals who have DSM-IV-TR major depressive disorder, psychoses, current substance or alcohol abuse, conduct disorder, or a diagnosed psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. Individuals whose parents or guardians have current substance abuse or a diagnosed psychiatric disorder or other condition that, in the opinion of the investigators, would impede adherence with the study Each participant will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant s assent, as well as the consent of the parent or guardian, will be documented in the medical record. All participants will be informed of their right to withdraw from the study. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Freedman DS, Khan LK, Dietz WH, Srinivasan SR, Berenson GS. Relationship of childhood obesity to coronary heart disease risk factors in adulthood: the Bogalusa Heart Study. Pediatrics. 2001 Sep;108(3):712-8. — View Citation
Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. Inter-relationships among childhood BMI, childhood height, and adult obesity: the Bogalusa Heart Study. Int J Obes Relat Metab Disord. 2004 Jan;28(1):10-6. — View Citation
Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. — View Citation
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