The research study is designed is to determine whether children's acceptance of low sugar snacks, most preferred level of sweet and salty taste, and dietary intake of added sugars changes after repeated exposure to snacks lower in sweetness when compared to the control group.
This is a longitudinal, randomized, within- and between- subject study of children and their mothers to determine whether children's repeated exposure to snacks lower in sweetness and mothers' educational lessons about dental health and nutrition (intervention group) affects children's acceptance of low sugar snacks, most preferred level of sweet and salty taste, and dietary intake of added sugars when compared to the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
172
Children in the experimental group get repeated exposure to lower sweet snacks and mothers get education lessons on dental care, reading food labels, portion size, and nutrition.
Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Children's Dietary Intake of Energy From Added Sugar (Tsp/d)
Children's dietary intake of added sugar (tsp/d) was determined from Automated Self-Administered Recall System (ASA24) at baseline, mid-trial, and end of trial.
Time frame: From T1 (baseline Temple visit at start of intervention) to T2 (Month 2, mid-trial), T3 (Month 4, end of intervention) and T4 (Month 5, which is 1 month post-intervention follow-up)
Caregiver's Dietary Intake of Energy From Added Sugar (Tsp/d)
Caregivers' dietary intake of added sugar (tsp/d) was determined from Automated Self-Administered Recall System (ASA24) at baseline, mid-trial, and end of trial.
Time frame: At T1 (baseline Temple visit at start of intervention) to T2 (Month 2, mid-trial), T3 (Month 4, end of intervention) and T4 (Month 5, which is 1 month post-intervention follow-up)
Children's Liking of Snacks Low in Sweetness (SET 1 FOODS)
Children's indicated liking of two sets of lower sweetness intervention snack foods (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), assessed on separate occasions. Using hedonic face scales, children indicated their like or dislike for each food. Liking data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis shows the count of and percentage of children who liked SET 1 STRAWBERRY-BANANA YOGURT AND APPLE SLICES at the end of the intervention.
Time frame: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention). Liking assessments of Set 1 and Set 2 foods were performed at separate laboratory visits.
Children's Liking of Snacks Low in Sweetness (SET 2 FOODS)
Children's indicated liking of two sets of lower sweetness intervention snack foods (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), assessed on separate occasions. Using hedonic face scales, children indicated their like or dislike for each food. Liking data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis shows the number and percentage of children who liked SET 2 HUMMUS AND BABY CARROTS at the end of the intervention.
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Time frame: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention). Liking assessments of Set 1 and Set 2 foods were performed at separate laboratory visits.
Children's Intake (g) of Snacks Low in Sweetness (SET 1 FOODS)
Children's intake of novel snacks in grams using weighed intake methods; higher intake and consummatory responses indicate greater acceptance. Children's ad libitum intake of two sets of lower sweetness intervention snack foods was assessed on separate occasion (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), a protocol that directly followed assessment of liking. Weighed intakes were used to measure children's intake of each food in grams. Intake data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis presents INTAKE in GRAMS of SET 1 STRAWBERRY-BANANA YOGURT AND APPLE SLICES at the END OF TRIAL.
Time frame: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's Intake (g) of Snacks Low in Sweetness (SET 2 FOODS)
Children's intake of novel snacks in grams using weighed intake methods; higher intake and consummatory responses indicate greater acceptance. Children's ad libitum intake of two sets of lower sweetness intervention snack foods was assessed on separate occasion (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), a protocol that directly followed assessment of liking. Weighed intakes were used to measure children's intake of each food in grams. Intake data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis presents INTAKE in GRAMS of SET 2 HUMMUS and BABY CARROTS at the END OF TRIAL.
Time frame: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's Body Mass Index Z-scores (BMIz)
Children's height was measured in cm and weight in kg; these measures were used to calculate child BMI (kg/m2). Child BMI z-scores were calculated with CDC 2000 growth charts using the LMS method, which standardizes a child's BMI relative to a reference population of U.S. children of the same age and sex. The BMI z-score indicates how many standard deviations the child's BMI is above or below the CDC age- and sex-specific average, with higher positive values indicating higher relative body size compared to children of the same age and sex in the CDC reference population. This analysis compares child BMIz by arm at the END OF TRIAL.
Time frame: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's Stable Isotope Biomarker of Added Sugar Intake
Carbon stable isotopes were assessed using ratio mass spectrometry methods using hair samples collected at the start (T0) and end of 4-month intervention (T4).
Time frame: From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention)
Monitoring of Individual Differences in Parenting Feeding Styles
Mothers will complete the 19-item Caregivers Feeding Styles Questionnaire \[CFSQ\]. Each item is scored from 1 (never) to 5 (always). Mean item scores were used to assess parental demandingness (12 items) and responsiveness (7 items), with a possible range of 1 to 5 for each scale where higher scores indicate higher levels of the construct. This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
Time frame: T1 (baseline Temple visit at start of intervention)
Monitoring of Individual Differences in Children's Appetitive Drive
Mothers will complete the 26-item Children's Eating Behavior Questionnaire \[CEBQ\]. Each item is scored from 1 (never) to 5 (always) and are averaged and categorized into aspects of child eating (e.g., enjoyment of food, food responsiveness, satiety responsiveness, emotional overeating; emotional undereating, food fussiness); higher numbers reflect more of the behavior. This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
Time frame: T1 (baseline Temple visit at start of intervention)
Monitoring of Individual Differences in Children's Behavioral Activation
Children's behavioral activation was measured using the Behavioral Activation Scale, a 20-item self-report questionnaire assessing children's sensitivity to reward and approach motivation across 3 subscales: drive (4 items), fun seeking (4 items), and reward responsiveness (5 items). Each question is answered using a 4-point Likert-type scale, with possible scores ranging from 1 (not true) -4 (very true). Scores for each of the three subscales are calculated as the sum of all items on the subscale, with higher scores indicating higher levels of the construct. Possible scores ranges for subscales are as follows: drive (4-16); fun seeking (4-16), and reward responsiveness (5-20). This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
Time frame: T1 (baseline Temple visit at start of intervention)
Monitoring of Individual Differences in Mothers' Palatable Eating Motivation
Mothers will complete the 19-item Palatable Eating Motive Scales (PEMS) questionnaire; each item is scored from 1 (almost never/never exhibits behavior) to 5 (almost always/always exhibits behavior). Scores are averaged and categorized to reflect motives for intake of palatable foods (e.g., to socialize, cope, fit in or conform, for reward enhancement); higher numbers reflect more of the motivation.This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
Time frame: T1 (baseline Temple visit at start of intervention)