Clinical trial NCT02624713: Development of Eating Disorders Symptoms Among Children
Official title: Development of Eating Disorders Symptoms Among Children Who Took Part in Family-based Obesity Treatment and Among Their Siblings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders Symptoms
Keywords: eating disorder
childhood obesity
family based treatment
Lead sponsor: Tel Hai College
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2015-12-08
Enrollment: 159
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is an open clinical study with two branches: a retrospective follow up and a prospective follow up
Primary purpose: TREATMENT

Brief summary: Randomized Clinical Trial, the research will be composed of two parts in order to examine the research question: a combination of controlled randomized retrospective research and prospective cohort research

Prospective Cohort Research:

The research groups - families coming for treatment in "Active Maccabi" clinics in the Northern Region, Israel. Approximately 30 families.

Retrospective Random Controlled Research

1. The research group - families that have completed an intervention program of "Active Maccabi" Northern Region, Israel,within the past two to three years. The families will be requested to attend a follow-up meeting of all family members in which they will answer questionnaires. Approximately 66 families.
2. The control groups - families who did not participate in the program who have a child between the age 7-14 who has suffered from obesity/weight (over the past 2-3 years), in correlation with the child in the intervention group. Approximately 66 families.

Hypotheses of the research:

1. Status of the weight of the child being treated and of his siblings will be higher than that at the end of the program.
2. Indication of the obesogenic environment of families participating in the program will be lower in comparison with families not participating in the program.
3. The rate of eating disorder symptoms among children who participated in the program will be lower in comparison with those of the obese/overweight child in families who were not the program.
4. The rate of eating disorder symptoms among siblings who participated in the program will be lower than that of siblings in families not in the program.

Detailed description: Duration of the Research -Prospective Cohort Research: 6 months of intervention. 8 months follow-up.

Research Instruments

1. Anthropometric measurements of all children in the family (height, weight and BMI). BMI per centile examinations according to age.
2. An acquaintance questionnaire and demographic details - to be answered by parents
3. A FEAQ_R questionnaire to be answered by the parents (only in the prospective research group). The questionnaire will examine the obesogenic burden in the family. A column will be added for each sibling of relevant age. The questionnaire will be valid in English and Hebrew. The psychometric characteristics of the questionnaire: Alpha cronbach - validity 0.84; Reliability 0.78 Trt
4. Eat-26 (cheat) questionnaire to be answered by the children and their siblings. The questionnaire will examine the risk of developing an eating disorder.

Eligibility criteria: Inclusion Criteria:

1. Families who participated in "Active Maccabi
2. Families who signed a consent form
3. Families who attended 80% of the sessions

exclusion criteria:

1. Families who don't fill in questionnaires at all stages of the research
2. Families in which the parents refuse to sign a consent form
3. Families in the control group who receive treatment in more than three sessions by a dietician in the community

Primary outcomes:
measure: Number of Participants With >20 on the 26 Children Eating Attitudes Test
timeFrame: Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (after a total of 14 months from baseline, time 3)"
measure: Family Eating and Activity Habits Questionnaire 32
timeFrame: Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (after a total of 14 months from baseline, time 3)"
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Hai College
name: Moria Golan, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Endevelt R, Elkayam O, Cohen R, Peled R, Tal-Pony L, Michaelis Grunwald R, Valinsky L, Porath A, Heymann AD. An intensive family intervention clinic for reducing childhood obesity. J Am Board Fam Med. 2014 May-Jun;27(3):321-8. doi: 10.3122/jabfm.2014.03.130243.
citation: Epstein LH, Paluch RA, Raynor HA. Sex differences in obese children and siblings in family-based obesity treatment. Obes Res. 2001 Dec;9(12):746-53. doi: 10.1038/oby.2001.103.
citation: Golan M, Crow S. Targeting parents exclusively in the treatment of childhood obesity: long-term results. Obes Res. 2004 Feb;12(2):357-61. doi: 10.1038/oby.2004.45.
citation: Golan M, Fainaru M, Weizman A. Role of behaviour modification in the treatment of childhood obesity with the parents as the exclusive agents of change. Int J Obes Relat Metab Disord. 1998 Dec;22(12):1217-24. doi: 10.1038/sj.ijo.0800749.
citation: Golan M, Weizman A. Reliability and validity of the Family Eating and Activity Habits Questionnaire. Eur J Clin Nutr. 1998 Oct;52(10):771-7. doi: 10.1038/sj.ejcn.1600647.
citation: Maloney MJ, McGuire JB, Daniels SR. Reliability testing of a children's version of the Eating Attitude Test. J Am Acad Child Adolesc Psychiatry. 1988 Sep;27(5):541-3. doi: 10.1097/00004583-198809000-00004. No abstract available.