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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

107 participants

Primary outcome timeframe

Change from baseline at 4 months

Results posted on

2022-06-27

Participant Flow

Participant milestones

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

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 months

Change in the consumption of fruits and vegetables (portions / day) in the short term (at the end of the intervention)

Outcome measures

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 months

Change in the consumption of dairy (portions / day) in the short term (at the end of the intervention)

Outcome measures

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 months

Change in the consumption of processed foods (portions / day) in the short term (at the end of the intervention)

Outcome measures

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 months

Change in the consumption of sugary drinks (portions / day) in the short term (at the end of the intervention)

Outcome measures

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 months

Change in the consumption of natural water (portions / day) in the short term (at the end of the intervention)

Outcome measures

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 months

Change in the consumption of fruits and vegetables (portions / day) in the medium term (3 months after the end of the intervention)

Outcome measures

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 months

Change in the consumption of dairy (portions / day) in the medium term (3 months after the end of the intervention)

Outcome measures

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 months

Change in the consumption of processed foods (portions / day) in the medium term (3 months after the end of the intervention)

Outcome measures

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 months

Change in the consumption of sugary drinks (portions / day) in the medium term (3 months after the end of the intervention)

Outcome measures

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 months

Change in the consumption of natural water (portions / day) in the medium term (3 months after the end of the intervention)

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: (+52) 3310585200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place