Adolescent BehaviorNCT03136289
Family Consumer Behaviors, Adolescent Prediabetes and Diabetes
An observational study of Adolescent Behavior, run by Rutgers University.
Trial summary
The aim of this study was to examine the association between family consumer behaviors (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- Family Consumer Behaviors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,520 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Child, Adult
Study population: The study included NHANES subjects from 2007-2010 who were 12-19 years old and from households where an eligible person had administered the consumer behavior questionnaire (CBQ). The CBQ was developed in partnership with the Economic Research Service of the US Department of Agriculture and has been a part of NHANES from 2007-2010. A total of 2,520 children and adolescents met the eligibility criteria for the study.
Who may be able to join
- NHANES subjects from 2007-2010 who were 12-19 years old Households where an eligible person had administered the consumer behavior questionnaire (CBQ).
Who cannot join
- Age <12 or >19 years Pregnancy
About this study
Official title: Family Consumer Behaviors, Adolescent Prediabetes and Diabetes in the National Health and Nutrition Examination Survey (2007-2010)
The aim of this study was to examine the association between family consumer behaviors (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes.
Read the detailed description
NHANES is a nationwide cross-sectional survey conducted by the Centers for Disease Control and Prevention (CDC), a detailed description of which is available elsewhere. The NHANES administers annual face-to-face health surveys in a nationally representative sample of civilian, non-institutionalized households in the US. In addition to core questions documenting household demographic and health characteristics, survey instruments collect information on current health and disease status, including several questionnaires on health quality indicators and lifestyle practices. Besides survey instruments, NHANES collects information on select clinical examinations and laboratory tests.
The study will include NHANES subjects from 2007-2010 who were 12-19 years old and from households where an eligible person had administered the consumer behavior questionnaire (CBQ). The CBQ was developed in partnership with the Economic Research Service of the US Department of Agriculture and has been a part of NHANES from 2007-2010. A total of 2,520 children and adolescents met the eligibility criteria for the study.
Food Availability and Expenditure The primary variables of interest for the study included household healthy food availability and supermarket spending on food that was assessed in the CBQ. Availability will be examined for five food items in the household including fruits, dark green vegetables, fat-free/low fat milk, salty snacks, and soft drinks. The responses for each item were ordinal, ranging from always, most of the time, sometimes, rarely, to never. Dark green vegetables included fresh dried, canned and frozen vegetables, and interviewers were instructed to exclude lettuce. Salty snacks included chips and crackers, but not nuts. The types of milk considered low-fat were skim or 0% and 1%. Soft drinks included soda, fruit-flavored drink and fruit punch; while 100% juice or sports drinks were excluded.
A composite variable that incorporated answers to all the five food items will be created for food availability. First, a decreasing score ranging from 5 to 1 was assigned from "always" to "never" responses for the healthy food items including fruits, dark green vegetables, and fat-free/low fat milk; whereas an increasing score ranging from 1 to 5 was assigned for "always" to "never" response for unhealthy food items including salty snacks and soft drinks. A cumulative score will be calculated for each participant that ranged from 5 to 25, where a higher value indicated higher availability of healthy food(s) in the household. A cumulative score will only be calculated for participants with a non-missing response on all five questions.
Food spending will be examined by the amount of money (in US Dollars) the household spent in the past 30 days on supermarket store purchases, non-food items, food at other stores, eating out and carryout/delivered foods. Non-food spending was asked as a part of supermarket store spending and it included money used towards cleaning and paper supplies, pet food, alcoholic beverages and cigarettes. This will be first subtracted from the total supermarket spending to give supermarket spending on food items alone. It will then be divided by the total food spending of the household (sum of the above food spending questions) to also calculate the proportion of spending on supermarket store food items.
Prediabetes and Diabetes The primary outcome of interest will be adolescent prediabetes and diabetes. Pre-diabetics will be included with diabetics to determine the impact of family consumers on a wider range of glycemic status. Additionally, they are the most amenable to dietary and lifestyle changes in preventing further progression to overt diabetes. These will be computed by the individual's hemoglobin A1c (A1c) status. A1c values are relatively stable after collection15 and reflect 3 months of glycemic control. It has been shown to have less day-to-day as well as inter-subject and intra-subject variability16,17. The HbA1c concentration is expressed directly as %HbA1c. A participant was considered pre-diabetic or diabetic if he/she had an A1c ≥ 5.7 % (39 mmol/mol)18.
Other Variables Covariates were selected as those designated most important in the association between adolescent obesity and consumer behaviors in existing literature. These included socio-demographic characteristics including age, gender, race, parental educational attainment and income levels, and household size. Physical activity, which was defined as participation in vigorous activity such as sports, fitness and recreational activities that increased the heart rate, was also examined.
Statistical Analysis The prevalence (%) with standard error (SE) of prediabetes and diabetes will be estimated across different levels of study covariates. First, the distribution of responses to the five food availability questions as well as the cumulative healthy food availability score will be examined for the study population. The cumulative score will be dichotomized on the median value of 14.96 and divided into high and low availability of healthy food. Next, a chi square test will be used to look at the relationship between healthy food availability and adolescent prediabetes and diabetes in the population. When examining the monthly household supermarket spending in USD, a log transformation will be used due to a large degree of positive skew. The proportion of supermarket spending will be dichotomized at the median value of 0.67 to divide the study population into high versus low supermarket food spending. The prevalence (%) with SE of high healthy food availability and geometric mean USD with 95% confidence interval (CI) of monthly household supermarket food spending will be summarized across various socio-demographic and physical activity levels of the study population. A chi-square test will be used to demonstrate significant differences in the prevalence of high healthy food availability and high supermarket spending proportion for each demographic characteristic.
An analysis of variance will be carried out to examine the relationship between healthy food availability (from the cumulative score) and supermarket spending. Subsequent correlation analyses were used to examine the inter-relationships between several variables in the consumer behavior questionnaire (data not shown).
The unadjusted and adjusted associations between adolescent prediabetes and diabetes will be first examined with high healthy food availability (versus low availability) and then with log supermarket food expenditure in USD, using separate logistic regression models. Three multivariate models were established for each association: where the first was adjusted for age and gender, the second also adjusted for income and race, and the third further adjusted for education, physical activity and household size. The fully adjusted models will finally be stratified by gender to check for effect modification. The above associations were estimated using prevalence odds ratio (OR) and their corresponding 95% CI.
All statistical analyses will be conducted with SAS version 9.3 (SAS Institute Inc., Cary, North Carolina), and the statistical significance level was 0.05, unless otherwise specified. Since NHANES is a complex probability sample, stratification and clustering of the design as well as sampling weights were incorporated into the analysis for proper estimation of nationally representative effect size and SE.
- Conditions
- Adolescent Behavior
- Being tested
- Family Consumer Behaviors
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Consumer BehaviorsBehavioural
The relationship between family consumer behaviours (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent prediabetes and diabetes.
A1c>5.7%
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startDec 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sairaman Nagarajan, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136289
- Sponsor's protocol ID
- Pro2014000064
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Secondary de-identified CDC NHANES data, no IPD
Publications
Nagarajan S, Khokhar A, Holmes DS, Chandwani S. Family Consumer Behaviors, Adolescent Prediabetes and Diabetes in the National Health and Nutrition Examination Survey (2007-2010). J Am Coll Nutr. 2017 Sep-Oct;36(7):520-527. doi: 10.1080/07315724.2017.1327828. Epub 2017 Aug 30.
PubMed 28853988
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Consumer Behaviors, Adolescent Prediabetes and Diabetes in the National Health and Nutrition Examination Survey (2007-2010)
- ClinicalTrials.gov ID
- NCT03136289
- Acronym / sponsor ID
- Pro2014000064
- Conditions
- Adolescent Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,520 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to examine the association between family consumer behaviors (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes.
Detailed description
NHANES is a nationwide cross-sectional survey conducted by the Centers for Disease Control and Prevention (CDC), a detailed description of which is available elsewhere. The NHANES administers annual face-to-face health surveys in a nationally representative sample of civilian, non-institutionalized households in the US. In addition to core questions documenting household demographic and health characteristics, survey instruments collect information on current health and disease status, including several questionnaires on health quality indicators and lifestyle practices. Besides survey instruments, NHANES collects information on select clinical examinations and laboratory tests.
The study will include NHANES subjects from 2007-2010 who were 12-19 years old and from households where an eligible person had administered the consumer behavior questionnaire (CBQ). The CBQ was developed in partnership with the Economic Research Service of the US Department of Agriculture and has been a part of NHANES from 2007-2010. A total of 2,520 children and adolescents met the eligibility criteria for the study.
Food Availability and Expenditure The primary variables of interest for the study included household healthy food availability and supermarket spending on food that was assessed in the CBQ. Availability will be examined for five food items in the household including fruits, dark green vegetables, fat-free/low fat milk, salty snacks, and soft drinks. The responses for each item were ordinal, ranging from always, most of the time, sometimes, rarely, to never. Dark green vegetables included fresh dried, canned and frozen vegetables, and interviewers were instructed to exclude lettuce. Salty snacks included chips and crackers, but not nuts. The types of milk considered low-fat were skim or 0% and 1%. Soft drinks included soda, fruit-flavored drink and fruit punch; while 100% juice or sports drinks were excluded.
A composite variable that incorporated answers to all the five food items will be created for food availability. First, a decreasing score ranging from 5 to 1 was assigned from "always" to "never" responses for the healthy food items including fruits, dark green vegetables, and fat-free/low fat milk; whereas an increasing score ranging from 1 to 5 was assigned for "always" to "never" response for unhealthy food items including salty snacks and soft drinks. A cumulative score will be calculated for each participant that ranged from 5 to 25, where a higher value indicated higher availability of healthy food(s) in the household. A cumulative score will only be calculated for participants with a non-missing response on all five questions.
Food spending will be examined by the amount of money (in US Dollars) the household spent in the past 30 days on supermarket store purchases, non-food items, food at other stores, eating out and carryout/delivered foods. Non-food spending was asked as a part of supermarket store spending and it included money used towards cleaning and paper supplies, pet food, alcoholic beverages and cigarettes. This will be first subtracted from the total supermarket spending to give supermarket spending on food items alone. It will then be divided by the total food spending of the household (sum of the above food spending questions) to also calculate the proportion of spending on supermarket store food items.
Prediabetes and Diabetes The primary outcome of interest will be adolescent prediabetes and diabetes. Pre-diabetics will be included with diabetics to determine the impact of family consumers on a wider range of glycemic status. Additionally, they are the most amenable to dietary and lifestyle changes in preventing further progression to overt diabetes. These will be computed by the individual's hemoglobin A1c (A1c) status. A1c values are relatively stable after collection15 and reflect 3 months of glycemic control. It has been shown to have less day-to-day as well as inter-subject and intra-subject variability16,17. The HbA1c concentration is expressed directly as %HbA1c. A participant was considered pre-diabetic or diabetic if he/she had an A1c ≥ 5.7 % (39 mmol/mol)18.
Other Variables Covariates were selected as those designated most important in the association between adolescent obesity and consumer behaviors in existing literature. These included socio-demographic characteristics including age, gender, race, parental educational attainment and income levels, and household size. Physical activity, which was defined as participation in vigorous activity such as sports, fitness and recreational activities that increased the heart rate, was also examined.
Statistical Analysis The prevalence (%) with standard error (SE) of prediabetes and diabetes will be estimated across different levels of study covariates. First, the distribution of responses to the five food availability questions as well as the cumulative healthy food availability score will be examined for the study population. The cumulative score will be dichotomized on the median value of 14.96 and divided into high and low availability of healthy food. Next, a chi square test will be used to look at the relationship between healthy food availability and adolescent prediabetes and diabetes in the population. When examining the monthly household supermarket spending in USD, a log transformation will be used due to a large degree of positive skew. The proportion of supermarket spending will be dichotomized at the median value of 0.67 to divide the study population into high versus low supermarket food spending. The prevalence (%) with SE of high healthy food availability and geometric mean USD with 95% confidence interval (CI) of monthly household supermarket food spending will be summarized across various socio-demographic and physical activity levels of the study population. A chi-square test will be used to demonstrate significant differences in the prevalence of high healthy food availability and high supermarket spending proportion for each demographic characteristic.
An analysis of variance will be carried out to examine the relationship between healthy food availability (from the cumulative score) and supermarket spending. Subsequent correlation analyses were used to examine the inter-relationships between several variables in the consumer behavior questionnaire (data not shown).
The unadjusted and adjusted associations between adolescent prediabetes and diabetes will be first examined with high healthy food availability (versus low availability) and then with log supermarket food expenditure in USD, using separate logistic regression models. Three multivariate models were established for each association: where the first was adjusted for age and gender, the second also adjusted for income and race, and the third further adjusted for education, physical activity and household size. The fully adjusted models will finally be stratified by gender to check for effect modification. The above associations were estimated using prevalence odds ratio (OR) and their corresponding 95% CI.
All statistical analyses will be conducted with SAS version 9.3 (SAS Institute Inc., Cary, North Carolina), and the statistical significance level was 0.05, unless otherwise specified. Since NHANES is a complex probability sample, stratification and clustering of the design as well as sampling weights were incorporated into the analysis for proper estimation of nationally representative effect size and SE.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study included NHANES subjects from 2007-2010 who were 12-19 years old and from households where an eligible person had administered the consumer behavior questionnaire (CBQ). The CBQ was developed in partnership with the Economic Research Service of the US Department of Agriculture and has been a part of NHANES from 2007-2010. A total of 2,520 children and adolescents met the eligibility criteria for the study.
Key inclusion criteria (1 listed)
- NHANES subjects from 2007-2010 who were 12-19 years old Households where an eligible person had administered the consumer behavior questionnaire (CBQ).
Key exclusion criteria (1 listed)
- Age <12 or >19 years Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Consumer BehaviorsThe relationship between family consumer behaviours (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes. | Behavioural | – |
Primary outcome
Adolescent prediabetes and diabetes.
Time frame: 1 week
A1c>5.7%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Derived from this study: PubMed 28853988Nagarajan S, Khokhar A, Holmes DS, Chandwani S. Family Consumer Behaviors, Adolescent Prediabetes and Diabetes in the National Health and Nutrition Examination Survey (2007-2010). J Am Coll Nutr. 2017 Sep-Oct;36(7):520-527. doi: 10.1080/07315724.2017.1327828. Epub 2017 Aug 30.
- Individual participant dataSharing planned: No. Secondary de-identified CDC NHANES data, no IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Behavior, run by Rutgers University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent prediabetes and diabetes. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.