Please select the eligibility criteria that correspond to the clinical trial below.
Title: Children and Parents Partnering Together to Manage Their Weight
Brief Summary: Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise. Using a two-group, repeated measures experimental design, this proposed study will test a 12-week intensive intervention on nutrition, exercise and coping skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight status, and adiposity. The study will take this intervention to the community in which children and parents live, working with four schools in Alamance-Burlington County, NC, and four schools in Wilson County in the early evening. A total of 356 Black, Hispanic, and White children with a BMI \>85th percentile and 356 parents with a BMI \>25 kg/m2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group. Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up). Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents (BMI); and adiposity in the children and parents (waist circumference and triceps and subscapular skinfolds). Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight in children and parents is urgently needed, and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black, Hispanic, and White children and parents in other communities to assist them to manage their weight.


Options:
A: Inclusion Criteria: Inclusion criteria for children include:

* ability to speak, write, and read in English
* a BMI \> 85th percentile for age and gender
* at least one parent or guardian with a BMI \>25
* assent and their parent or guardian's consent to their participation

Inclusion criteria for parents or guardians include:

* ability to speak, write, and read in English
* a BMI \>25
* a 2nd, 3rd or 4th grade child with a BMI \> 85th percentile for age and gender
* reside with the child; and consent to join the study

Exclusion Criteria: Parents and children will be excluded if either has a:

* history of a heart murmur
* congenital heart disease
* family history of sudden death
* history of psychological problems such as claustrophobia that would prevent participation in group classes
* participation in another clinical trial or intervention
* Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites
B: Inclusion Criteria:

* Teens and parents of any gender, ethnicity/race, or socioeconomic status.
* Teens 14 to 16 years of age who are freshmen and sophomores taking a health class at one of the participating high schools.
* Teens who assent to participation.
* Teens with a custodial parent who consents for themselves and their teen's participation in the study.
* Teens who can speak and read in English (educational instruction in Arizona High Schools is conducted in English)

Exclusion Criteria:

* Teens who are under age 14 will be excluded because:

  * They are not likely to be enrolled in high school, and
  * They are unlikely to have sufficient cognitive development to benefit from the proposed intervention
* Teens who are over age 16 will be excluded for two key reasons:

  * We believe that the cognitive development of and social expectations for older teens requires a more complex and flexible intervention than that proposed, and
  * Teens need to be available for 12 month follow-up sessions (our pilot studies indicated that this becomes less likely once teens are old enough to leave/graduate from high school, emancipate from parents, and/or leave home).
C: Inclusion Criteria:

* All children in 3-5 grades who provide parental consent and child assent will be eligible to participate in the project.

Exclusion Criteria:

* Participants who meet the following exclusion criteria will not be considered for participation.
* Do not provide consent
* unable or unwilling to adhere to project procedures
D: Inclusion Criteria:

* BMI \> 27 kg/m2 (adults)

Exclusion Criteria:

* weight loss of more than 5kg in the last 2 months
* pregnancy, breastfeeding
* patients with:

  * severe heart failure
  * impaired hepatic or renal function
  * anaemia
  * disturbed coagulation (biopsies will not be taken in those subjects)
  * infection, malabsorption
  * severe hypertension
  * cancer within the last 5 years
  * eating disorders or any other psychiatric condition that would interact with the trial intervention
  * any other endocrine disorder
* changes of smoking habits or diets within the last 3 months prior to study inclusion

Answer: A