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Development of Eating Disorders Symptoms Among Children

Primary Purpose

Eating Disorders Symptoms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
obesity treatment
Sponsored by
Tel Hai College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders Symptoms focused on measuring eating disorder, childhood obesity, family based treatment

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Retrospective Random Controlled Research

    The Prospective study

    Arm Description

    In 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 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).

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 18, 2015
    Last Updated
    January 29, 2020
    Sponsor
    Tel Hai College
    Collaborators
    Maccabi Healthcare Services, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02624713
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tel Hai College
    Collaborators
    Maccabi Healthcare Services, Israel

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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. 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: Status of the weight of the child being treated and of his siblings will be higher than that at the end of the program. Indication of the obesogenic environment of families participating in the program will be lower in comparison with families not participating in the program. 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. 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 Anthropometric measurements of all children in the family (height, weight and BMI). BMI per centile examinations according to age. An acquaintance questionnaire and demographic details - to be answered by parents 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 Eat-26 (cheat) questionnaire to be answered by the children and their siblings. The questionnaire will examine the risk of developing an eating disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders Symptoms
    Keywords
    eating disorder, childhood obesity, family based treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This research is an open clinical study with two branches: a retrospective follow up and a prospective follow up
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    159 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Retrospective Random Controlled Research
    Arm Type
    Other
    Arm Description
    In 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.
    Arm Title
    The Prospective study
    Arm Type
    Other
    Arm Description
    The 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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    obesity treatment
    Other Intervention Name(s)
    family based obesity treatment
    Intervention Description
    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. 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. Physical activity groups for the children, with individual physical fitness monitoring. twice a week for 6 months. .
    Primary Outcome Measure Information:
    Title
    Number of Participants With >20 on the 26 Children Eating Attitudes Test
    Description
    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.
    Time Frame
    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)"
    Title
    Family Eating and Activity Habits Questionnaire 32
    Description
    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.
    Time Frame
    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)"

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Families who participated in "Active Maccabi Families who signed a consent form Families who attended 80% of the sessions exclusion criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Moria Golan, PROFESSOR
    Organizational Affiliation
    Tel Hai College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24808110
    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.
    Results Reference
    background
    PubMed Identifier
    11743058
    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.
    Results Reference
    background
    PubMed Identifier
    14981230
    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.
    Results Reference
    background
    PubMed Identifier
    9877257
    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.
    Results Reference
    background
    PubMed Identifier
    9805227
    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.
    Results Reference
    background
    PubMed Identifier
    3182615
    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.
    Results Reference
    background

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    Development of Eating Disorders Symptoms Among Children

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