Trial Outcomes & Findings for New Skills - No Scores Research Study (NCT NCT04254666)

NCT ID: NCT04254666

Last Updated: 2023-12-13

Results Overview

To assess teens' willingness to eat specific foods, parents completed a modified Food Frequency Questionnaire that contained a list of 108 common foods to report their teen's willingness to eat various food items ("no, my teen will not eat this" and "yes, my teen will eat this"). Parents who reported that they have not served the food item to their child were coded as missing. Parent responses were dichotomized to indicate teen willingness to eat the food and summed within their respective food groups (vegetables, fruits, proteins, grains, and dairy). The mean number of foods for each food group was used for analysis. Higher values indicate an increase in the participants' willingness to eat the foods in the specified food group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Baseline and Post intervention (within 1 month)

Results posted on

2023-12-13

Participant Flow

Participant milestones

Participant milestones
Measure
Physical Literacy & Food Literacy Intervention
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Skills - No Scores Research Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Age, Categorical
<=18 years
6 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Post intervention (within 1 month)

Physical Self-Concept will be measured using the Very Short Form of the Physical Self-Inventory-Intellectual Disability (PSI-VSF-ID). The PSI-VSF-ID is a 12-item questionnaire that measures six dimensions of self-concept: 1) Global Self-Concept; 2) Physical Self-Worth; 3) Sport Competence; 4) Physical Attractiveness; 5) Physical Condition; and 6) Physical Strength. Four response options range from "very true" to "not at all true", and a visual answer scale uses smiling/frowning faces effective for use with adolescents with ID. Higher scores indicate higher self-concept in the aforementioned domains. We will examine changes in participants' physical self-concept between baseline and post-intervention.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Motivation and Confidence in Physical Activity
Baseline - Global Self-concept (Range: 0 - 4)
3.42 score on a scale
Standard Deviation 0.74
Motivation and Confidence in Physical Activity
Post Intervention - Global Self-concept (Range: 0 - 4)
3.42 score on a scale
Standard Deviation 0.80
Motivation and Confidence in Physical Activity
Baseline - Physical Self-worth (Range: 0 - 4)
3.17 score on a scale
Standard Deviation 0.98
Motivation and Confidence in Physical Activity
Post Intervention - Physical Self-worth (Range: 0 - 4)
3.42 score on a scale
Standard Deviation 0.92
Motivation and Confidence in Physical Activity
Baseline - Physical Condition (Range: 0 - 4)
2.50 score on a scale
Standard Deviation 1.26
Motivation and Confidence in Physical Activity
Post Intervention - Physical Condition (Range: 0 - 4)
2.75 score on a scale
Standard Deviation 0.69
Motivation and Confidence in Physical Activity
Baseline - Sport Competence (Range: 0 - 4)
2.92 score on a scale
Standard Deviation 0.80
Motivation and Confidence in Physical Activity
Post Intervention - Sport Competence (Range: 0 - 4)
3.33 score on a scale
Standard Deviation 0.52
Motivation and Confidence in Physical Activity
Baseline - Physical Attractiveness (Range: 0 - 4)
3.08 score on a scale
Standard Deviation 0.66
Motivation and Confidence in Physical Activity
Post Intervention - Physical Attractiveness (Range: 0 - 4)
3.17 score on a scale
Standard Deviation 0.88
Motivation and Confidence in Physical Activity
Baseline - Physical Strength (Range: 0 - 4)
2.92 score on a scale
Standard Deviation 0.86
Motivation and Confidence in Physical Activity
Post Intervention - Physical Strength (Range: 0 - 4)
3.17 score on a scale
Standard Deviation 0.68

PRIMARY outcome

Timeframe: Baseline and Post intervention (within 1 month)

Movement/Motor Skills will be assessed using the Test of Gross Motor Development (3rd ed). The TGMD-3 assesses 13 fundamental motor skills related to 1) locomotor skills and 2) ball skills. The TGMD-3 is a direct observation skill assessment with 3-5 performance criteria for each skill. We will assess: skipping, two-foot jumping, one-foot hopping, sideways sliding, overhand throw, underhand throw, catch, hand dribble, and kick. The TGMD-3 will be administered via Zoom at baseline and post-12 weeks.A trained professional will review and code the video-recorded TGMD-3 performance on each skill and provide a score at baseline and post-test. For all of the ranges higher scores equal greater motor proficiency.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Movement/Motor Skills
Post Intervention - Dribble (Range: 0 - 6)
3.0 score on a scale
Standard Deviation 1.9
Movement/Motor Skills
Baseline - Ball Skills (Range: 0 - 36)
16.2 score on a scale
Standard Deviation 7.1
Movement/Motor Skills
Baseline - Total Motor Skills (Range: 0 - 66) (higher indicate better motor skills)
24.0 score on a scale
Standard Deviation 10.6
Movement/Motor Skills
Post Intervention - Total Motor Skills (Range: 0 - 66)
27.8 score on a scale
Standard Deviation 14.2
Movement/Motor Skills
Baseline - Locomotive Skills (Range: 0 - 30)
7.8 score on a scale
Standard Deviation 6.4
Movement/Motor Skills
Post Intervention - Locomotive Skills (Range: 0-30)
7.7 score on a scale
Standard Deviation 5.5
Movement/Motor Skills
Baseline - Hop (Range: 0 - 8)
2.17 score on a scale
Standard Deviation 1.83
Movement/Motor Skills
Post Intervention - Hop (Range: 0 - 8)
2.5 score on a scale
Standard Deviation 2.17
Movement/Motor Skills
Baseline - Skip (Range: 0 - 6)
1.33 score on a scale
Standard Deviation 2.07
Movement/Motor Skills
Post Intervention - Skip (Range: 0 - 6)
0.66 score on a scale
Standard Deviation 1.03
Movement/Motor Skills
Baseline - Jump (Range: 0 - 8)
2.67 score on a scale
Standard Deviation 1.51
Movement/Motor Skills
Post Intervention - Jump (Range: 0 - 8)
2.83 score on a scale
Standard Deviation 2.48
Movement/Motor Skills
Baseline - Slide (Range: 0 - 8)
1.67 score on a scale
Standard Deviation 1.03
Movement/Motor Skills
Post Intervention - Slide (Range: 0 - 8)
1.67 score on a scale
Standard Deviation 0.82
Movement/Motor Skills
Post Intervention - Ball Skills (Range: 0 - 36)
20.2 score on a scale
Standard Deviation 9
Movement/Motor Skills
Baseline - Dribble (Range: 0 - 6)
2.17 score on a scale
Standard Deviation 2.14
Movement/Motor Skills
Baseline - Catch (Range: 0 - 6)
5.0 score on a scale
Standard Deviation 1.1
Movement/Motor Skills
Post Intervention - Catch (Range: 0 - 6)
5.0 score on a scale
Standard Deviation 1.55
Movement/Motor Skills
Baseline - Kick (Range: 0 - 8)
2.0 score on a scale
Standard Deviation 1.41
Movement/Motor Skills
Post Intervention - Kick (Range: 0 - 8)
2.83 score on a scale
Standard Deviation 2.93
Movement/Motor Skills
Baseline - Overhand Throw (Range: 0 - 8)
1.0 score on a scale
Standard Deviation 1.67
Movement/Motor Skills
Post Intervention - Overhand Throw (Range: 0 - 8)
1.83 score on a scale
Standard Deviation 2.48
Movement/Motor Skills
Baseline - Underhand Throw (Range: 0 - 8)
3.67 score on a scale
Standard Deviation 3.14
Movement/Motor Skills
Post Intervention - Underhand Throw (Range: 0 - 6)
4.83 score on a scale
Standard Deviation 1.94

PRIMARY outcome

Timeframe: Baseline and Post intervention (within 1 month)

The adequacy and predilection for physical activity subscale of the Canadian Assessment of Physical Literacy - 2nd Ed (CAPL-2) Questionnaire estimates the participant's desire to participate in physical activity. The 6-item questionnaire subscale includes 3 items that assess perceived adequacy (i.e., self-perception that one has the capability to achieve an acceptable standard of success conceptualized by the self and others) and 3 items that assess perceived predilection for physical activity (i.e., likelihood of selecting physical activity over sedentary behavior when given the choice). This is a shortened and refined version of the original CAPL Questionnaire. The adequacy and predilection subscale, called "What's Most Like Me?", uses an alternative response choice format to present statements about preferences and feelings about physical activity. For all ranges higher scores indicate higher levels of perceived self concept, motivation, and competency for physical activity.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Desire to Participate in Physical Activity
Baseline - Perceived Competence for PA (Range: 0 - 3)
1.5 score on a scale
Standard Deviation 1.38
Desire to Participate in Physical Activity
Post Intervention - Perceived Competence for PA (Range: 0 - 3)
2.67 score on a scale
Standard Deviation 0.52
Desire to Participate in Physical Activity
Baseline - Intrinsic Motivation for PA (Range: 0 - 3)
2.0 score on a scale
Standard Deviation 0.89
Desire to Participate in Physical Activity
Post Intervention - Intrinsic Motivation for PA (Range: 0 - 3)
2.67 score on a scale
Standard Deviation 0.52
Desire to Participate in Physical Activity
Baseline - Perceived Adequacy for Sports and Active Games (Summed score; Range: 0 - 6)
4.17 score on a scale
Standard Deviation 1.94
Desire to Participate in Physical Activity
Post Intervention - Perceived Adequacy for Sports and Active Games (Summed score; Range: 0 - 6)
4.67 score on a scale
Standard Deviation 1.86

PRIMARY outcome

Timeframe: Baseline and Post intervention (within 1 month)

Will be measured with a hands-on Food Knowledge/Skills test adapted from knowledge tests for typically developing children and children with ID developed by the investigative team. Participants will be asked to classify individual foods into food groups (e.g., an apple belongs in the fruit group), and other healthy eating concepts such as identifying whole grains, choosing the healthiest meal between two pictures of plates with food on them, and identifying beverages that have less sugar. For each item, answers will be scored as correct or incorrect (0 or 1) or "I don't know" (0) and summed for a total of percent correct. We will examine changes in participants' food knowledge/skills between baseline and post-intervention. Higher scores indicate increased knowledge.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Healthy Food Knowledge.
Baseline - Identifying the Healthier Snack (Range: 0 - 3)
2.33 score on a scale
Standard Deviation 1.03
Healthy Food Knowledge.
Post Intervention - Identifying the Healthier Snack (Range: 0 - 3)
2.33 score on a scale
Standard Deviation 1.21
Healthy Food Knowledge.
Baseline - Identifying Whole Grain Foods (Range: 0 - 5)
3.17 score on a scale
Standard Deviation 0.75
Healthy Food Knowledge.
Post Intervention - Identifying Whole Grain Foods (Range: 0 - 5)
3.33 score on a scale
Standard Deviation 0.82
Healthy Food Knowledge.
Baseline - Identifying Drinks with Less Sugar (Range: 0 - 2)
1.5 score on a scale
Standard Deviation 0.84
Healthy Food Knowledge.
Post Intervention - Identifying Drinks with Less Sugar (Range: 0 - 2)
1.83 score on a scale
Standard Deviation 0.41
Healthy Food Knowledge.
Baseline - Identifying the Healthier Meal (Range: 0 - 2)
1.33 score on a scale
Standard Deviation 1.03
Healthy Food Knowledge.
Post Intervention - Identifying the Healthier Meal (Range: 0 - 2)
1.83 score on a scale
Standard Deviation 0.41

PRIMARY outcome

Timeframe: Baseline and Post intervention (within 1 month)

To assess teens' willingness to eat specific foods, parents completed a modified Food Frequency Questionnaire that contained a list of 108 common foods to report their teen's willingness to eat various food items ("no, my teen will not eat this" and "yes, my teen will eat this"). Parents who reported that they have not served the food item to their child were coded as missing. Parent responses were dichotomized to indicate teen willingness to eat the food and summed within their respective food groups (vegetables, fruits, proteins, grains, and dairy). The mean number of foods for each food group was used for analysis. Higher values indicate an increase in the participants' willingness to eat the foods in the specified food group.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Foods Participant is Willing to Eat
Baseline - Vegetables (mean)
20.83 number of foods in food group
Standard Deviation 4.58
Foods Participant is Willing to Eat
Post Intervention - Vegetables (mean)
23.5 number of foods in food group
Standard Deviation 4.81
Foods Participant is Willing to Eat
Baseline - Fruits (mean)
16.17 number of foods in food group
Standard Deviation 4.67
Foods Participant is Willing to Eat
Post Intervention - Fruits (mean)
17.00 number of foods in food group
Standard Deviation 4.43
Foods Participant is Willing to Eat
Baseline - Proteins (mean)
13.83 number of foods in food group
Standard Deviation 1.94
Foods Participant is Willing to Eat
Post Intervention - Proteins (mean)
14.83 number of foods in food group
Standard Deviation 1.60
Foods Participant is Willing to Eat
Baseline - Grains (mean)
11.50 number of foods in food group
Standard Deviation 1.64
Foods Participant is Willing to Eat
Post Intervention - Grains (mean)
13.17 number of foods in food group
Standard Deviation 1.17
Foods Participant is Willing to Eat
Baseline - Dairy (mean)
3.50 number of foods in food group
Standard Deviation 0.55
Foods Participant is Willing to Eat
Post Intervention - Dairy (mean)
3.83 number of foods in food group
Standard Deviation 0.41

PRIMARY outcome

Timeframe: Baseline and Post Intervention (within 1 month)

Participants will be asked to classify individual foods into food groups (e.g., an apple belongs in the fruit group). For each item, answers are scored as correct or incorrect (0 or 1) or "I don't know" (0) and summed for a total of percent correct. Higher percentage scores indicate increased ability to classify foods correctly. Range is 0-100%.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Food Categorization
Baseline Categorization of food into food groups (% Correct)
64.7 percent correct
Standard Deviation 47.8
Food Categorization
Post Intervention Categorization of food into food groups (% Correct)
79.3 percent correct
Standard Deviation 40.5

SECONDARY outcome

Timeframe: Week 12

Will be measured with a survey of enjoyment, satisfaction, and perceived appropriateness of key elements of the program. Survey will include closed-ended questions with Likert scale response categories, and will be verbally administered.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Participant (Teen) Enjoyment and Satisfaction
Percent reporting liking the sport skills part of the program
100 % participants indicating agreement
Participant (Teen) Enjoyment and Satisfaction
percent reporting liking the sports skills practice between sessions
50 % participants indicating agreement
Participant (Teen) Enjoyment and Satisfaction
percent reporting liking the nutrition education
83 % participants indicating agreement
Participant (Teen) Enjoyment and Satisfaction
percent reporting liking the taste tests
83 % participants indicating agreement
Participant (Teen) Enjoyment and Satisfaction
percent reporting liking trying two new foods each week
100 % participants indicating agreement
Participant (Teen) Enjoyment and Satisfaction
percent reporting that the sports skills were just right
83 % participants indicating agreement
Participant (Teen) Enjoyment and Satisfaction
percent reporting the nutrition education sessions were just right
83 % participants indicating agreement

SECONDARY outcome

Timeframe: Week 12

Will be measured with a survey of satisfaction and perceptions of the program that queries key elements of the program. Survey will include closed-ended questions with Likert scale response categories, and space for open-ended comments and feedback.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=6 Participants
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Parent Satisfaction
% parents reporting that program was effective in motivating their teen to eat healthy foods.
83 % parents indicating agreement
Parent Satisfaction
% parents reporting program was effective in increasing teens interest physical activity/sports
50 % parents indicating agreement
Parent Satisfaction
% parents reporting they would recommend the program to other families of teens with ID
83 % parents indicating agreement
Parent Satisfaction
% parents reporting overall satisfaction with the program
83 % parents indicating agreement

SECONDARY outcome

Timeframe: Weekly for 12 weeks

Attendance was recorded at each weekly session of the 12-week intervention. Absences and withdrawals were documented. The total % of sessions that all participants attended is reported.

Outcome measures

Outcome measures
Measure
Physical Literacy & Food Literacy Intervention
n=72 total # of sessions
This is a pilot project to assess the feasibility of a physical literacy and food literacy intervention for adolescents with ID ages 12-16 years. Physical Literacy \& Food Literacy Intervention.: A 12-week intervention designed to expose adolescents with ID to a variety of sports skills and healthy eating concepts to equip them with skills and confidence to participate in sports and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 75 minutes virtually; 35 minutes will focus on sport skills activities with 35 minutes devoted to healthy eating.
Attendance
87.5 % sessions the participants attended

Adverse Events

Physical Literacy & Food Literacy Intervention

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

Carol Curtin

University of Massachusetts Chan Medical School

Phone: 774-455-6527

Results disclosure agreements

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