Eating Disorders Symptoms
Conditions
Keywords
eating disorder, childhood obesity, family based treatment
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.
Interventions
BEHAVIORALobesity 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. .
Sponsors
Maccabi Healthcare Services, Israel
Tel Hai College
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This research is an open clinical study with two branches: a retrospective follow up and a prospective follow up
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With >20 on the 26 Children Eating Attitudes Test | 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. |
| Family Eating and Activity Habits Questionnaire 32 | 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 (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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospective Study 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. | 78 |
| Retrospective Random Controlled Research 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), . | 81 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 0 |
Baseline characteristics
| Characteristic | Total | Prospective Study | Retrospective Random Controlled Research |
|---|---|---|---|
| Age, Categorical <=18 years | 159 Participants | 78 Participants | 81 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 88 Participants | 49 Participants | 39 Participants |
| Sex: Female, Male Male | 71 Participants | 29 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 81 |
| other Total, other adverse events | 0 / 78 | 0 / 81 |
| serious Total, serious adverse events | 0 / 78 | 0 / 81 |
Outcome results
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.
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)
Population: 42 Parents answered the questionnaire before and after the program, and follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obesity Treatment | Family Eating and Activity Habits Questionnaire 32 | Difference between time 2 and time 1 | -16.2 score on a scale | Standard Error 4.9 |
| Obesity Treatment | Family Eating and Activity Habits Questionnaire 32 | Difference between time 3 and time 2 | -23.2 score on a scale | Standard Error 5.7 |
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.
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Obesity Treatment | Number of Participants With >20 on the 26 Children Eating Attitudes Test | 26 Participants |
| Prospective Research | Number of Participants With >20 on the 26 Children Eating Attitudes Test | 4 Participants |