Development of Eating Disorders Symptoms Among Children

NCT ID: NCT02624713

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-02-28

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.

Conditions

Eating Disorders Symptoms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retrospective Random Controlled Research

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.

Group Type: OTHER

obesity treatment

Intervention Type: BEHAVIORAL

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. .

The Prospective study

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).

Group Type: OTHER

obesity treatment

Intervention Type: BEHAVIORAL

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. .

Interventions

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. .

Intervention Type: BEHAVIORAL

Other Intervention Names

family based obesity treatment

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

Tel Hai College

OTHER

Sponsor Role: lead

Responsible Party

suzan berman

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moria Golan, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

Tel Hai College

References

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.

Reference Type: BACKGROUND

PMID: 24808110 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11743058 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14981230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9877257 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9805227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3182615 (View on PubMed)

Other Identifiers

telhaicollege

Identifier Type: -

Identifier Source: org_study_id