Eating Disorders Symptoms Clinical Trial
Official title:
Development of Eating Disorders Symptoms Among Children Who Took Part in Family-based Obesity Treatment and Among Their Siblings
| Verified date | January 2020 |
| Source | Tel Hai College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 159 |
| Est. completion date | February 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 8 Years to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Tel Hai College | Maccabi Healthcare Services, Israel |
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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)" | |
| Primary | 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)" |