Development, Child Clinical Trial
Official title:
Downshifting Sweet Preference and Added Sugar Intake During Snacking
Verified date | December 2023 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Monell Chemical Senses Center | Philadelphia | Pennsylvania |
United States | Temple University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Monell Chemical Senses Center, National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Concordance of hair biomarker for added sugar intake among mother-child dyads | Estimates of added sugar intake will be determined via stable isotope ratio mass spectrometry methods on hair samples collected from mother and child at the start (T0) and end of 4-month intervention (T4) end of the 4-month intervention period (T4) to determine concordance among mother-child dyads | Relationship between hair biomarker levels at timepoint 0 (baseline Temple visit at start of intervention) and at T4 (4 month visit=end of intervention) | |
Primary | Change is being assessed in the children's liking of snacks low in sweetness | Children's grouping of the taste of novel snacks as liked, ok, or disliked as determined by lab-based measurements of liking using a picture-based 3-point hedonic scale depicting "yummy", "yucky", and "just-okay" responses; following the grouping of snacks into these categories, snacks will be ranked for most liked to most disliked [range: 4-6]. | From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
Primary | Change is being assessed in the children's intake of snacks low in sweetness | Children's intake of novel snacks in grams using weighed intake methods and behavioral parameters of intake from digital recordings; higher intake and consummatory responses indicate greater acceptance. | From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay) | |
Primary | Change is being assessed in dietary intake of energy from added sugar | Dietary intake (kcal/d) will be determined from Automated Self-Administered Recall System (ASA24) completed by mothers for her child and herself. | From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
Secondary | Change is being assessed in levels of hair biomarker for added sugar intake | Estimates of added sugar intake will be determined via stable isotope ratio mass spectrometry methods on hair samples collected at the start (T0) and end of 4-month intervention (T4) | From timepoint 0 (baseline Temple visit at start of intervention) to T4 (4 month visit=end of intervention) | |
Secondary | Change is being assessed in liking-based dietary intake survey | Dietary intake of foods as determined by measurements of the degree of dislike or like for a variety of foods and beverages (e.g., sweet/fat, fruit, vegetables) as well as experiences and activities; range: -100 (maximal dislike) to 100 (maximal like)]. The items in a given category (e.g., fruits; sweets/fats; healthy foods) are combined and averaged [range: -100 to 100; higher numbers reflect greater liking and intake]. The preschool adapted liking survey (PALS) is used for children and the adult liking survey (ALS) is used for mothers | From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
Secondary | Monitoring of individual differences in parenting feeding styles | Mothers will complete the 19-item Child Feeding Styles and Practices Questionnaire [CFSQ]. Each item is scored from 1 (never) to 5 (always). Scores are averaged and categorized into one of four feeding styles: authoritative, authoritarian, indulgent and uninvolved; higher scores represent more of the feeding style | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
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 | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
Secondary | Monitoring of individual differences in children's palatable eating motivation | Mothers will complete the 19-item Kids Palatable Eating Motive Scales (KPEMS) questionnaire; each item is scored from 1 (child almost never/never exhibits behavior) to 5 (child 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 | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
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 | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay) | |
Secondary | Monitoring of weight | Children's weight will be measured in kg; these measures will be converted to weight for age Z scores which provide measures of anthropometry adjusted age and sex. | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay) | |
Secondary | Monitoring of height | Children's height will be measured in cm; these measures will be converted to height for age Z scores which provide measures of anthropometry adjusted age and sex. | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay) | |
Secondary | Monitoring of body mass index | Children's height will be measured in cm and weight in kg; these measures will be combined to determine BMI (kg/m2) and then converted to BMI Z scores which provide measures of anthropometry adjusted age and sex. | From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay) |
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