Trial Outcomes & Findings for Development of Eating Disorders Symptoms Among Children (NCT NCT02624713)
NCT ID: NCT02624713
Last Updated: 2020-02-10
Results Overview
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.
COMPLETED
NA
159 participants
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)"
2020-02-10
Participant Flow
Participant milestones
| Measure |
Prospective Study
The Prospective study had only an intervention group. The intervention group included families who participated in the "Maccabi Active" program in 2015 in the northern district. 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). Anthropometric measurements were taken and a Cheat 26 questionnaire was given to each child in the families. The parents filled personal details and a questionnaire for mapping the family eating habits (FEAHQ-33).
|
Retrospective Controlled Research
Retrospective 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..
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.
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.
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|---|---|---|
|
Overall Study
STARTED
|
78
|
81
|
|
Overall Study
COMPLETED
|
64
|
81
|
|
Overall Study
NOT COMPLETED
|
14
|
0
|
Reasons for withdrawal
| Measure |
Prospective Study
The Prospective study had only an intervention group. The intervention group included families who participated in the "Maccabi Active" program in 2015 in the northern district. 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). Anthropometric measurements were taken and a Cheat 26 questionnaire was given to each child in the families. The parents filled personal details and a questionnaire for mapping the family eating habits (FEAHQ-33).
|
Retrospective Controlled Research
Retrospective 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..
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
0
|
Baseline Characteristics
Development of Eating Disorders Symptoms Among Children
Baseline characteristics by cohort
| Measure |
Prospective Study
n=78 Participants
obesity treatment: 1.Parents' education groups for nutrition and healthy behavior with a dietitian and a social worker every 2 weeks for 5 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.
|
Retrospective Random Controlled Research
n=81 Participants
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), .
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
78 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)"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.
Outcome measures
| Measure |
Obesity Treatment
n=81 Participants
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), .
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 physi
|
Prospective Research
n=78 Participants
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). Anthropometric measurements were taken and the Eat 26 questionnaire was given to each child in the families. The parents filled personal details and answered questions regarding the family eating habits.
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|---|---|---|
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Number of Participants With >20 on the 26 Children Eating Attitudes Test
|
26 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 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)"Population: 42 Parents answered the questionnaire before and after the program, and follow up.
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.
Outcome measures
| Measure |
Obesity Treatment
n=42 Participants
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), .
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 physi
|
Prospective Research
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). Anthropometric measurements were taken and the Eat 26 questionnaire was given to each child in the families. The parents filled personal details and answered questions regarding the family eating habits.
|
|---|---|---|
|
Family Eating and Activity Habits Questionnaire 32
Difference between time 2 and time 1
|
-16.2 score on a scale
Standard Error 4.9
|
—
|
|
Family Eating and Activity Habits Questionnaire 32
Difference between time 3 and time 2
|
-23.2 score on a scale
Standard Error 5.7
|
—
|
Adverse Events
Prospective Study
Retrospective Random Controlled Research
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place