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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC016616 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Monell Chemical Senses Center | OTHER |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Sweet | Experimental | Children in intervention group will be provided with daily snacks lower in added sugar and sweetness and their mothers will receive educational lessons on dental care, reading food labels, and nutrition that support the goals of reducing "sweet" exposure and added sugar intake. |
|
| Regular Sweet | Sham Comparator | Children in the regular sweet control group will be provided with common snacks fed to children of this age and mothers will be given education lessons on portion size, physical activity, sleep, screen time and, at the end of the trial, dental care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Sweet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Mennella, PhD | Monell Chemical Senses Center | Principal Investigator |
| Jennifer O Fisher, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monell Chemical Senses Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| Temple University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21227904 | Background | Mennella JA, Lukasewycz LD, Griffith JW, Beauchamp GK. Evaluation of the Monell forced-choice, paired-comparison tracking procedure for determining sweet taste preferences across the lifespan. Chem Senses. 2011 May;36(4):345-55. doi: 10.1093/chemse/bjq134. Epub 2011 Jan 12. | |
| 24198311 | Background | Nash SH, Kristal AR, Hopkins SE, Boyer BB, O'Brien DM. Stable isotope models of sugar intake using hair, red blood cells, and plasma, but not fasting plasma glucose, predict sugar intake in a Yup'ik study population. J Nutr. 2014 Jan;144(1):75-80. doi: 10.3945/jn.113.182113. Epub 2013 Nov 6. |
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dbGAP
2022 and for one year
To be developed
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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).
Of 172 enrolled participants, 140 participants (70 mothers, 70 children) reflecting 70 caregiver-child dyads were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Sweet | Children in intervention group were provided with daily snacks lower in added sugar and sweetness and their mothers will receive educational lessons on dental care, reading food labels, and nutrition that support the goals of reducing "sweet" exposure and added sugar intake. Low 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. |
| FG001 | Regular Sweet | Children in the regular sweet control group were provided with common snacks fed to children of this age and mothers will be given education lessons on portion size, physical activity, sleep, screen time and, at the end of the trial, dental care. Regular Sweet: Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 dyads);baseline characteristics are reported here for child and caregiver age, sex, race, and ethnicity.by arm (Low Sweet, n=35 children, 35 mothers. Regular Sweet n=35 children, 35 mothers)
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Sweet | Children in intervention group were provided with daily snacks lower in added sugar and sweetness and their mothers will receive educational lessons on dental care, reading food labels, and nutrition that support the goals of reducing "sweet" exposure and added sugar intake. Low 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | CHILD AGE | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CHILD AGE.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 70 participants (35 caregiver-child dyads) were randomized to each arm (Low Sweet, Regular Sweet) for a total of 140 participants (70 caregiver-child dyads); primary outcomes are reported here on children's daily intake of added sugars.(tsp/d) by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Posted | Least Squares Mean | Standard Error | 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) |
|
During the 4 month intervention and 1 month follow up; reported for 140 participants (70 mothers, 70 children) representing 70 mother-child dyads
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Sweet | Children in intervention group were provided with daily snacks lower in added sugar and sweetness and their mothers will receive educational lessons on dental care, reading food labels, and nutrition that support the goals of reducing "sweet" exposure and added sugar intake. Low 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Orlet Fisher, PhD | Temple University | 2157070921 | jofisher@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2021 | Jan 8, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2025 | Jan 8, 2026 | SAP_001.pdf |
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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.
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Participants and outcome assessors will be blind to hypotheses and group assignment. Investigators will be blind to the group assignment during statistical analyses.
| Regular Sweet | Behavioral | Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time. |
|
| 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. | 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. | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) |
| 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). | 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. | 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. | 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. | 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. | T1 (baseline Temple visit at start of intervention) |
| Philadelphia |
| Pennsylvania |
| 19140 |
| United States |
| 24637844 | Background | Mennella JA, Finkbeiner S, Lipchock SV, Hwang LD, Reed DR. Preferences for salty and sweet tastes are elevated and related to each other during childhood. PLoS One. 2014 Mar 17;9(3):e92201. doi: 10.1371/journal.pone.0092201. eCollection 2014. |
| 11693591 | Background | Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792. |
| 27103060 | Background | Vandeweghe L, Verbeken S, Moens E, Vervoort L, Braet C. Strategies to improve the Willingness to Taste: The moderating role of children's Reward Sensitivity. Appetite. 2016 Aug 1;103:344-352. doi: 10.1016/j.appet.2016.04.017. Epub 2016 Apr 19. |
| 15604035 | Background | Hughes SO, Power TG, Orlet Fisher J, Mueller S, Nicklas TA. Revisiting a neglected construct: parenting styles in a child-feeding context. Appetite. 2005 Feb;44(1):83-92. doi: 10.1016/j.appet.2004.08.007. Epub 2004 Nov 13. |
| 29746892 | Background | Sharafi M, Rawal S, Fernandez ML, Huedo-Medina TB, Duffy VB. Taste phenotype associates with cardiovascular disease risk factors via diet quality in multivariate modeling. Physiol Behav. 2018 Oct 1;194:103-112. doi: 10.1016/j.physbeh.2018.05.005. Epub 2018 May 8. |
| 23230636 | Background | Martignon S, Gonzalez MC, Tellez M, Guzman A, Quintero IK, Saenz V, Martinez M, Mora A, Espinosa LF, Castiblanco GA. Schoolchildren's tooth brushing characteristics and oral hygiene habits assessed with video-recorded sessions at school and a questionnaire. Acta Odontol Latinoam. 2012;25(2):163-70. |
| 20148789 | Background | Mennella JA, Pepino MY, Lehmann-Castor SM, Yourshaw LM. Sweet preferences and analgesia during childhood: effects of family history of alcoholism and depression. Addiction. 2010 Apr;105(4):666-75. doi: 10.1111/j.1360-0443.2009.02865.x. Epub 2010 Feb 9. |
| 41833907 | Derived | Mennella JA, Coffman DL, Merchan MT, Croce CM, Smethers AD, Fisher JO. Exposure to low-sweet snacks and caregiver nutritional and dental health education lowered children's added sugar intake: a randomized controlled trial. Am J Clin Nutr. 2026 Jul;124(1):101272. doi: 10.1016/j.ajcnut.2026.101272. Epub 2026 Mar 13. |
| 39978470 | Derived | Smethers AD, Fisher JO, Carney EM, Coffman DL, Mennella JA. Carbon stable isotope values in hair are associated with added sugar intake in adults but not young children: a cross-sectional study. Am J Clin Nutr. 2025 Apr;121(4):900-909. doi: 10.1016/j.ajcnut.2025.02.013. Epub 2025 Feb 18. |
| BG001 | Regular Sweet | Children in the regular sweet control group were provided with common snacks fed to children of this age and mothers will be given education lessons on portion size, physical activity, sleep, screen time and, at the end of the trial, dental care. Regular Sweet: Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Age, Continuous | CAREGIVER AGE | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CAREGIVER AGE.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Mean | Standard Deviation | years |
|
| Sex: Female, Male | CHILD SEX | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CHILD SEX.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Count of Participants | Participants |
|
| Sex: Female, Male | CAREGIVER SEX | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CAREGIVER SEX.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | CHILD ETHNICITY | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CHILD ETHNICITY.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | CAREGIVER ETHNICITY | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CAREGIVER ETHNICITY.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Count of Participants | Participants |
|
| Race (NIH/OMB) | CHILD RACE | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CHILD RACE.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Count of Participants | Participants |
|
| Race (NIH/OMB) | CAREGIVER RACE | 70 participants (35 mothers, 35 children) or 35 caregiver-child dyads were randomized to each arm for a total of 140 participants (70 mothers, 70 children) or 70 caregiver-child dyads; baseline characteristics are reported here for CAREGIVER RACE.by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Count of Participants | Participants |
|
| OG001 | Regular Sweet | Children in the regular sweet control group were provided with common snacks fed to children of this age and mothers will be given education lessons on portion size, physical activity, sleep, screen time and, at the end of the trial, dental care. Regular Sweet: Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time. |
|
|
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| Primary | 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. | 70 participants (35 caregiver-child dyads) were randomized to each arm (Low Sweet, Regular Sweet) for a total of 140 participants (70 caregiver-child dyads); primary outcomes are reported here on caregivers' daily intake of added sugars.(tsp/d) by arm (Low Sweet, n=35 children. Regular Sweet n=35 children) | Posted | Least Squares Mean | Standard Error | 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) |
|
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|
|
| Primary | 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. | Posted | Count of Participants | Participants | 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. |
|
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| Primary | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
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| Primary | 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. | Posted | Mean | Standard Error | grams | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) |
|
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|
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| Primary | 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. | Posted | Mean | Standard Error | grams | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | z-score | At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention) |
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| Secondary | 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). | We obtained evidence from a separate study that this measure is not a biomarker of added sugar in children: Smethers AD et al. Am J Clin Nutr. 2025.Apr;121(4):900-909. As such, samples were collected but the analysis was never completed and will never be completed because the measure can not be used for the intended purpose of evaluating changes in added sugar intake among children in low sweet and regular sweet groups at either timepoint. | Posted | Count of Participants | Participants | From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention) |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | T1 (baseline Temple visit at start of intervention) |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | T1 (baseline Temple visit at start of intervention) |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | T1 (baseline Temple visit at start of intervention) |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | T1 (baseline Temple visit at start of intervention) |
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| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Regular Sweet | Children in the regular sweet control group were provided with common snacks fed to children of this age and mothers will be given education lessons on portion size, physical activity, sleep, screen time and, at the end of the trial, dental care. Regular Sweet: Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time. | 0 | 70 | 0 | 70 | 0 | 70 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| End of trial |
|
| 1 month follow up |
|
| 6.0 |
Adjusted mean differences are for Low Sweet minus Regular Sweet arm comparisons |
| Superiority |
| Intent-to-treat (ITT) analyses analyzed participants in their assigned treatment group regardless of adherence or study completion. Mixed-effects models were used to evaluate the effect of group (arm) and phase of study (pre vs. post COVID-19 lockdown (March 2020), on the primary outcome of caregiver's daily intake of added sugar intake (tsp/d) at MID TRIAL. Restricted maximum likelihood estimation accounted for missing dietary data, assuming missing at random. | Mixed Models Analysis | All t-tests for individual coefficient estimates used Satterthwaite's approximation for computing degrees of freedom. | <0.001 | We adjusted for multiple comparisons using the Sidak correction for 4 tests per model. Each model included arm (0=regular sweet, 1=low sweet), time (baseline, midtrial, end of trial, 1-month follow-up), group × time interaction, and COVID phase. | Mean Difference (Mid-trial) | -17.6 | Standard Error of the Mean | 3.5 | 2-Sided | 95 | -24.5 | -10.7 | Adjusted mean differences are for Low Sweet minus Regular Sweet arm comparisons | Superiority |
| Intent-to-treat (ITT) analyses analyzed participants in their assigned treatment group regardless of adherence or study completion. Mixed-effects models were used to evaluate the effect of group (arm) and phase of study (pre vs. post COVID-19 lockdown (March 2020), on the primary outcome of caregiver's daily intake of added sugar intake (tsp/d) at END OF TRIAL. Restricted maximum likelihood estimation accounted for missing dietary data, assuming missing at random. | Mixed Models Analysis | All t-tests for individual coefficient estimates used Satterthwaite's approximation for computing degrees of freedom. | 0.01 | We adjusted for multiple comparisons using the Sidak correction for 4 tests per model. Each model included arm (0=regular sweet, 1=low sweet), time (baseline, midtrial, end of trial, 1-month follow-up), group × time interaction, and COVID phase. | Median Difference (Final Values) | -11.0 | Standard Error of the Mean | 3.6 | 2-Sided | 95 | -18.0 | -3.9 | Adjusted mean differences are for Low Sweet minus Regular Sweet arm comparisons | Superiority |
| Intent-to-treat (ITT) analyses analyzed participants in their assigned treatment group regardless of adherence or study completion. Mixed-effects models were used to evaluate the effect of group (arm) and phase of study (pre vs. post COVID-19 lockdown (March 2020), on the primary outcome of caregiver's daily intake of added sugar intake (tsp/d) at 1 MONTH FOLLOW UP. Restricted maximum likelihood estimation accounted for missing dietary data, assuming missing at random. | Mixed Models Analysis | All t-tests for individual coefficient estimates used Satterthwaite's approximation for computing degrees of freedom. | 0.002 | We adjusted for multiple comparisons using the Sidak correction for 4 tests per model. Each model included arm (0=regular sweet, 1=low sweet), time (baseline, midtrial, end of trial, 1-month follow-up), group × time interaction, and COVID phase. | Mean Difference (1 month follow up) | -12.7 | Standard Error of the Mean | 3.6 | 2-Sided | 95 | -19.7 | -5.6 | Adjusted mean differences are for Low Sweet minus Regular Sweet arm comparisons | Superiority |
| Apple slices |
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| Generalized linear mixed models with a binomial distribution and logit link function were fitted using maximum likelihood estimation (Laplace approximation) to evaluate children's liking of each of the Set 1 and Set 2 lower sweetness snacks at the end of the intervention. Models included fixed effects for group, time, and their interaction. This analysis reports children's liking of Set 1 APPLE SLICES. | Mixed Models Analysis | 0.53 | Slope | -1.8 | 2-Sided | 95 | -7.4 | 3.8 | Superiority |
| Baby Carrots |
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|
Generalized linear mixed models with a binomial distribution and logit link function were fitted using maximum likelihood estimation (Laplace approximation) to evaluate children's liking of each of the Set 1 and Set 2 lower sweetness snacks at the end of the intervention. Models included fixed effects for group, time, and their interaction. This analysis reports children's liking of Set 2 BABY CARROTS. |
| Mixed Models Analysis |
| 0.29 |
| Slope |
| -1.1 |
| 2-Sided |
| 95 |
| -3.3 |
| 1.1 |
| Superiority |
|
Repeated-measures analyses of variance (ANOVA), with Tukey's honestly significant difference post hoc tests, were used to examine the effect of treatment, time, and its interaction on ad libitum intake of low sweetness snacks. This analysis shows the effects of group/arm, time, and group x time interactions on children's intake of SET 1 APPLE SLICES |
| ANOVA |
| 0.75 |
Time x group interaction |
| Superiority |
| Repeated-measures analyses of variance (ANOVA), with Tukey's honestly significant difference post hoc tests, were used to examine the effect of treatment, time, and its interaction on ad libitum intake of low sweetness snacks. This analysis shows the group x time effects on children's intake of SET 2 BABY CARROTS in a model with group/arm, time, COVID-19 phase, and group x time interactions. | ANOVA | 0.46 | Time x group interaction | Superiority |
| Regression, Linear |
| 0.12 |
| Slope |
| 0.19 |
| 2-Sided |
| 95 |
| -0.05 |
| 0.43 |
| Superiority |
| 0.86 |
| Superiority |
| Enjoyment of food |
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| Desire to drink |
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| Satiety responsiveness |
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| Slowness in eating |
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| Emotional undereating |
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| Food fussiness |
|
| 0.68 |
| Superiority |
| ANOVA evaluated mean enjoyment of food by group at baseline. | ANOVA | 0.52 | Superiority |
| ANOVA evaluated mean desire to drink by group at baseline. | ANOVA | 0.09 | Superiority |
| ANOVA evaluated mean satiety responsiveness by group at baseline. | ANOVA | 0.47 | Superiority |
| ANOVA evaluated mean slowness in eating by group at baseline. | ANOVA | 1.0 | Superiority |
| ANOVA evaluated mean emotional undereating by group at baseline. | ANOVA | 0.89 | Superiority |
| ANOVA evaluated mean food fussiness by group at baseline. | ANOVA | 0.92 | Superiority |
| Reward responsiveness |
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| 0.49 |
| Superiority |
| ANOVA was used to evaluate mean differences in reward responsiveness by group at baseline. | ANOVA | 0.65 | Superiority |
| Reward Enhancement |
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| Conformity |
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