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Development of Eating Disorders Symptoms Among Children

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ClinicalTrials.gov Identifier: NCT02624713
Recruitment Status : Unknown
Verified December 2015 by suzan berman, Tel Hai College.
Recruitment status was:  Enrolling by invitation
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
suzan berman, Tel Hai College

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.

Condition or disease Intervention/treatment Phase
Eating Disorders Symptoms Behavioral: obesity treatment Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Eating Disorders Symptoms Among Children Who Took Part in Family-based Obesity Treatment and Among Their Siblings
Study Start Date : November 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
obesity treatment

Retrospective Random Controlled Research

  1. The research group - families that have completed an intervention program of "Active Maccabi" ,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), . Approximately 66 families.
Behavioral: obesity treatment
  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. .
Other Name: family based obesity treatment




Primary Outcome Measures :
  1. eating disorders symptoms [ Time Frame: 1 year ]
    Checking the score of the eat26 questionnaire. Test score>20 will be a sign to the risk of developing an eating disorder



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624713


Sponsors and Collaborators
Tel Hai College
Maccabi Healthcare Services, Israel
Investigators
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Principal Investigator: Moria Golan, PROFESSOR Tel Hai College

Publications of Results:
Other Publications:
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Responsible Party: suzan berman, principal investigator, Tel Hai College
ClinicalTrials.gov Identifier: NCT02624713     History of Changes
Other Study ID Numbers: telhaicollege
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by suzan berman, Tel Hai College:
eating disorder
childhood obesity
family based treatment
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders