Development, Child
Conditions
Keywords
Children, Sugar, Taste, Snacking, Biomarker, Mothers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALLow Sweet
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.
BEHAVIORALRegular Sweet
Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.
Sponsors
Temple University
Monell Chemical Senses Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blind to hypotheses and group assignment. Investigators will be blind to the group assignment during statistical analyses.
Intervention model description
The intervention group will receive snacks lower in added sugar and sweetness (children) and educational lessons on dental care, food labels, added sugar, and portion size (mothers) whereas the control group will receive typical snacks (children) and educational lessons on portion size, sleep, screen time, and physical activity (mothers). Control group will receive the educational lessons of the intervention group at the end of the trial.
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking mother 18 years or older * Mother has primary responsibility for the eligible child's care * Mother has primary responsibility for feeding the eligible child * Mother is responsible for purchasing food for the family * Mother must be willing to refrain from eating food and beverages high in added sugars in the eligible child's presence for the duration of the study
Exclusion criteria
* Child is in full-day daycare or school * Child is currently on a special diet (e.g. weight management programs) * Child has severe food allergies (e.g. gluten, peanuts) * Child has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis) * Mother is a current smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Intake (g) of Snacks Low in Sweetness (SET 1 FOODS) | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) | 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. |
| Children's Intake (g) of Snacks Low in Sweetness (SET 2 FOODS) | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) | 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. |
| Children's Dietary Intake of Energy From Added Sugar (Tsp/d) | 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) | 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. |
| Caregiver's Dietary Intake of Energy From Added Sugar (Tsp/d) | 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) | 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. |
| Children's Liking of Snacks Low in Sweetness (SET 1 FOODS) | 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 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. |
| Children's Liking of Snacks Low in Sweetness (SET 2 FOODS) | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of Individual Differences in Mothers' Palatable Eating Motivation | T1 (baseline Temple visit at start of intervention) | 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. |
| Monitoring of Individual Differences in Parenting Feeding Styles | T1 (baseline Temple visit at start of intervention) | 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. |
| Children's Body Mass Index Z-scores (BMIz) | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) | 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. |
| Children's Stable Isotope Biomarker of Added Sugar Intake | From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention) | 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). |
| Monitoring of Individual Differences in Children's Behavioral Activation | T1 (baseline Temple visit at start of intervention) | 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. |
| Monitoring of Individual Differences in Children's Appetitive Drive | T1 (baseline Temple visit at start of intervention) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulia Mennella, PhD
Monell Chemical Senses Center
PRINCIPAL_INVESTIGATORJennifer O Fisher, PhD
Temple University
Participant flow
Recruitment details
Of 172 enrolled participants, 140 participants (70 mothers, 70 children) reflecting 70 caregiver-child dyads were randomized.
Pre-assignment details
32 participants (16 mothers, 16 children) or 16 caregiver-child dyads were not randomized for failure to meet inclusion criteria (22 participants; 11 mothers, 11 children), failure to understand study tasks (4 participants; 2 mothers, 2 children), and failure to complete randomization screening tasks (6 participants; 3 mothers, 3 children).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
None listed