Trial Outcomes & Findings for Obesity Prevention in Head Start (NCT NCT03672227)

Last Updated: 2022-01-10

Results Overview

Dietary intake data will be collected via the Remote Food Photography Method over 2 lunches at Head Start among children in intervention and control classrooms to identify the proportion of children over-consuming energy during meals. Over-consumption is defined as an average per meal intake \> 332 kilocalories based on IOM recommendations regarding median energy intake recommended for 3 to 5 year olds' lunch in CACFP settings.

Recruitment status

COMPLETED

Study phase

Target enrollment

164 participants

Primary outcome timeframe

baseline, 6 weeks post-intervention

Results posted on

2022-01-10

Participant Flow

Participants include teachers, children within the classrooms of these teachers, and a parent of each child. Milestones used to break out number in each group enrolled.

Participant milestones

Participant milestones
Measure	Mealtime Matters Training This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions. Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.	Family Style Dining in Head Start This group of teachers will not get the nutrition training until the study has concluded.
Overall Study STARTED	112	52
Overall Study Teachers Started	8	6
Overall Study Children Started	52	23
Overall Study Parents Started	52	23
Overall Study COMPLETED	105	52
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Obesity Prevention in Head Start

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mealtime Matters Training n=112 Participants This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions. Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.	Family Style Dining in Head Start n=52 Participants This group of teachers will not get the nutrition training until the study has concluded.	Total n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	53 Participants n=5 Participants	23 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	28 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	22.4 years n=5 Participants	23.6 years n=7 Participants	23.3 years n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	41 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	11 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	19 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants	33 Participants n=7 Participants	116 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	41 Participants n=7 Participants	119 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants	52 participants n=7 Participants	164 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 weeks post-intervention

Population: Only children were included in this analysis.

Outcome measures

Outcome measures
Measure	Mealtime Matters Training n=46 Participants This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions. Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.	Family Style Dining in Head Start n=23 Participants This group of teachers will not get the nutrition training until the study has concluded.
Change in Percentage of Children Over-consuming Energy During Lunch Attributable to Mealtime Matters	-10.9 Percent of Participants	-56.5 Percent of Participants

SECONDARY outcome

Timeframe: baseline, 6 weeks post-intervention

Population: No data was collected from video and audio recordings due poor inter-rater reliability of trained coders.

Data will be collected at baseline among teachers in intervention and control classrooms. Two lunch periods will be video and audio recorded to identify teachers' feeding practices.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 hours

Population: Teachers who completed the 3-hour nutrition training

Data on teacher satisfaction will be collected via teacher questionnaires immediately post training to better understand whether the teachers found the training interesting, relevant, easy to implement, and useful.

Outcome measures

Outcome measures
Measure	Mealtime Matters Training n=7 Participants This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions. Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.	Family Style Dining in Head Start This group of teachers will not get the nutrition training until the study has concluded.
Number of Teachers Satisfied With Mealtime Matters [ Time Frame: Post-training ]	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks post-intervention

Population: Teachers assigned to Mealtime Matters Training

Data on teacher satisfaction will be collected via teacher questionnaires post-intervention to better understand whether the teachers found the training interesting, relevant, easy to implement, and useful.

Outcome measures

Outcome measures
Measure	Mealtime Matters Training n=8 Participants This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions. Mealtime Matters Training: This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.	Family Style Dining in Head Start This group of teachers will not get the nutrition training until the study has concluded.
Number of Teachers Satisfied With Mealtime Matters	8 Participants	—

Adverse Events

Mealtime Matters Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Style Dining in Head Start

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

Dr. Katherine Bauer

REGENTS OF THE UNIVERSITY OF MICHIGAN

Phone: (734)763-2546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place