Trial Outcomes & Findings for Modifications in the Eating Habits of Adolescents of Secondary Education as a Result of a Nutritional Intervention (NCT NCT03206476)
NCT ID: NCT03206476
Last Updated: 2022-06-27
Results Overview
Change in the consumption of fruits and vegetables (portions / day) in the short term (at the end of the intervention)
COMPLETED
NA
107 participants
Change from baseline at 4 months
2022-06-27
Participant Flow
Participant milestones
| Measure |
Intervention Group
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
Completed Short-term Evaluation (4 Months)
|
48
|
40
|
|
Overall Study
COMPLETED
|
42
|
37
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modifications in the Eating Habits of Adolescents of Secondary Education as a Result of a Nutritional Intervention
Baseline characteristics by cohort
| Measure |
Intervention Group
n=48 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=40 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.8 years
n=5 Participants
|
14.0 years
n=7 Participants
|
13.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 4 monthsChange in the consumption of fruits and vegetables (portions / day) in the short term (at the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=48 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=40 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Fruits and Vegetables in the Short Term
|
1.1 portions / day
Interval -1.0 to 2.3
|
0.3 portions / day
Interval -1.2 to 2.0
|
PRIMARY outcome
Timeframe: Change from baseline at 4 monthsChange in the consumption of dairy (portions / day) in the short term (at the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=48 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=40 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Dairy in the Short Term
|
0.1 portions / day
Interval -1.1 to 1.4
|
0.1 portions / day
Interval -0.6 to 1.7
|
PRIMARY outcome
Timeframe: Change from baseline at 4 monthsChange in the consumption of processed foods (portions / day) in the short term (at the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=48 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=40 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Processed Foods in the Short Term
|
-1.1 portions / day
Interval -3.9 to 1.5
|
-0.3 portions / day
Interval -2.0 to 1.6
|
PRIMARY outcome
Timeframe: Change from baseline at 4 monthsChange in the consumption of sugary drinks (portions / day) in the short term (at the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=48 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=40 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Sugary Drinks in the Short Term
|
0.8 portions / day
Interval -2.5 to 4.1
|
0.3 portions / day
Interval -1.8 to 1.9
|
PRIMARY outcome
Timeframe: Change from baseline at 4 monthsChange in the consumption of natural water (portions / day) in the short term (at the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=48 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=40 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Natural Water in the Short Term
|
1.1 portions / day
Interval -0.6 to 3.0
|
0.8 portions / day
Interval -0.4 to 2.3
|
SECONDARY outcome
Timeframe: Change from baseline at 7 monthsChange in the consumption of fruits and vegetables (portions / day) in the medium term (3 months after the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=42 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=37 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Fruits and Vegetables in the Medium Term
|
0.6 portions / day
Interval -1.0 to 1.9
|
-0.4 portions / day
Interval -1.4 to 1.2
|
SECONDARY outcome
Timeframe: Change from baseline at 7 monthsChange in the consumption of dairy (portions / day) in the medium term (3 months after the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=42 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=37 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Dairy in the Medium Term
|
0.3 portions / day
Interval -0.4 to 1.7
|
0.0 portions / day
Interval -0.9 to 0.4
|
SECONDARY outcome
Timeframe: Change from baseline at 7 monthsChange in the consumption of processed foods (portions / day) in the medium term (3 months after the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=42 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=37 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Processed Foods in the Medium Term
|
-0.5 portions / day
Interval -1.7 to 1.8
|
-0.4 portions / day
Interval -2.8 to 1.2
|
SECONDARY outcome
Timeframe: Change from baseline at 7 monthsChange in the consumption of sugary drinks (portions / day) in the medium term (3 months after the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=42 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=37 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Sugary Drinks in the Medium Term
|
1.1 portions / day
Interval -1.9 to 4.6
|
-1.0 portions / day
Interval -4.1 to 0.8
|
SECONDARY outcome
Timeframe: Change from baseline at 7 monthsChange in the consumption of natural water (portions / day) in the medium term (3 months after the end of the intervention)
Outcome measures
| Measure |
Intervention Group
n=42 Participants
Nutritional intervention based on the SCT and the TM
Nutritional intervention based on the SCT and the TM: Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
|
Control Group
n=37 Participants
Nutritional information
Nutritional information: Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
|
|---|---|---|
|
Change in the Consumption of Natural Water in the Medium Term
|
0.0 portions / day
Interval -1.0 to 3.1
|
0.0 portions / day
Interval -0.6 to 1.3
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dra. Gabriela Macedo Ojeda
Universidad de Guadalajara
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place