Development of Eating Disorders Symptoms Among Children
1 other identifier
interventional
159
0 countries
N/A
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.
- 3.Status of the weight of the child being treated and of his siblings will be higher than that at the end of the program.
- 4.Indication of the obesogenic environment of families participating in the program will be lower in comparison with families not participating in the program.
- 5.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.
- 6.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
February 10, 2020
CompletedFebruary 10, 2020
January 1, 2020
1.2 years
November 18, 2015
October 3, 2017
January 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With >20 on the 26 Children Eating Attitudes Test
Children Eating Attitudes Test- 26 items. The Children Eating Attitudes has been validated for children and adolescents. The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. Scores range from 0 (minimum) to 78 (maximum). Scores above 20 indicates a high level of concern about dieting, body weight, or problematic eating behaviors. Higher scores (above 20) are considered a worse outcome.
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)"
Family Eating and Activity Habits Questionnaire 32
Family Eating and Activity Habits questionnaire (FEAHQ-32) filled out by the participating parents (only in the prospective research group). The FEAHQ is a 32-item self-report instrument designed to assess the eating and activity habits of family members as well as obesogenic factors in the overall home environment (stimulus and behaviour patterns) related to weight. The higher the score, the greater the obsogenic load in a family so its a worse outcome. The lower the score, the less obsogenic load in the family so its a better outcome. There is no minimum or maximum score as reported by Golan \& Weizman, 1998 (See reference 5). The score varies from family to family according to the number of persons.The goal is to get a lower score relative to the initial score. The FEAHQ-32 has been validated in English and Hebrew. This measure was only used to assess the Prospective Research group, as also mentioned under research instruments in the detailed study description.
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)"
Study Arms (2)
Retrospective Random Controlled Research
OTHERIn the controlled retrospective follow up, (not random) 44 families participated with their 81 children and siblings. The intervention group included 18 families who participated in the "Maccabi Active" program (obesity treatment) in the years 2012-2013 in the northern district, with their 24 children (18 overweight children and 6 siblings). The control group included 26 families with their 57 children (27 children who had been overweight or obese in the years 2012-2013 when they were 8-14 years old and their 30 siblings). These families did not take part in a family based treatment for their overweight child. The parameters were measured at one set point time. All participants from both the control and research groups were evaluated at the follow-up and the data collected at follow-up is being reported collectively for the Retrospective Controlled Research branch.
The Prospective study
OTHERThe Prospective study had only an intervention group (obesity treatment). Forty-two families took part in this study, with 78 children: 48 overweight children and 30 siblings . The parameters were measured in three different times. Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (time 3).
Interventions
1. Parents' education groups for nutrition and healthy behavior with a dietician and a social worker every 2 weeks for5 months, for a total of 10 meetings. This part of the intervention aimed at providing parents with effective tools for modification of lifestyle and the family environment. 2. Children's individual therapy consisted of 6 individual meetings with a family physician, a physical therapist specializing in children's physical activity, and a dietician. This part of the intervention aimed at modifying nutrition and lifestyle; the physical therapist can help children incorporate physical activity into their routine. 3. Physical activity groups for the children, with individual physical fitness monitoring. twice a week for 6 months. .
Eligibility Criteria
You may qualify if:
- Families who participated in "Active Maccabi
- Families who signed a consent form
- Families who attended 80% of the sessions
You may not qualify if:
- Families who don't fill in questionnaires at all stages of the research
- Families in which the parents refuse to sign a consent form
- Families in the control group who receive treatment in more than three sessions by a dietician in the community
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel Hai Collegelead
- Maccabi Healthcare Services, Israelcollaborator
Related Publications (6)
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.
PMID: 24808110BACKGROUNDEpstein 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.
PMID: 11743058BACKGROUNDGolan 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.
PMID: 14981230BACKGROUNDGolan 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.
PMID: 9877257BACKGROUNDGolan 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.
PMID: 9805227BACKGROUNDMaloney 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.
PMID: 3182615BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Moria Golan
- Organization
- Tel-Hai College
Study Officials
- PRINCIPAL INVESTIGATOR
Moria Golan, PROFESSOR
Tel Hai College
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 18, 2015
First Posted
December 8, 2015
Study Start
November 1, 2015
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
February 10, 2020
Results First Posted
February 10, 2020
Record last verified: 2020-01