NCT02624713

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. 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. 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. 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. 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. 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. 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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

November 18, 2015

Results QC Date

October 3, 2017

Last Update Submit

January 29, 2020

Conditions

Keywords

eating disorderchildhood obesityfamily based treatment

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

OTHER

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.

Behavioral: obesity treatment

The Prospective study

OTHER

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).

Behavioral: obesity treatment

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. .

Also known as: family based obesity treatment
Retrospective Random Controlled ResearchThe Prospective study

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

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: 24808110BACKGROUND
  • 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.

    PMID: 11743058BACKGROUND
  • 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.

    PMID: 14981230BACKGROUND
  • 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.

    PMID: 9877257BACKGROUND
  • 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.

    PMID: 9805227BACKGROUND
  • 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.

    PMID: 3182615BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersPediatric Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Results Point of Contact

Title
Prof. Moria Golan
Organization
Tel-Hai College

Study Officials

  • Moria Golan, PROFESSOR

    Tel Hai College

    PRINCIPAL INVESTIGATOR

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
Model Details: This research is an open clinical study with two branches: a retrospective follow up and a prospective follow up
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