OverweightTOPSNCT02615158
Toddler Overweight Prevention Study Among Low-Income Families
A study testing Maternal Physical Activity and Nutrition, Parenting and Child Safety in people with Overweight and Obesity, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Depression
- What is being tested?
- Maternal Physical Activity and Nutrition, Parenting and Child Safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 yrs old
- Has child between 12-32 months
- Child able to walk
- Birth weight of child at least 5lbs. 8oz.
Who cannot join
- Mom cannot be pregnant
- No known congenital problems or disabilities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, School of Medicine
Baltimore, Maryland, 21201
University of Maryland
Baltimore, Maryland, 21201
About this study
Official title: Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention
The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.
Read the detailed description
Background:
Overweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching).
Overweight, defined as a BMI > 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% "at risk of overweight," defined as a BMI > 85th percentile (Ogden et al., 2006).
Dietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight.
Purpose of Study:
The investigators are collaborating with the Anne Arundel County, MD Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the University of Maryland's Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions.
The investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth.
In addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.
- Conditions
- Overweight, Obesity, Depression
- Being tested
- Maternal Physical Activity and Nutrition, Parenting, Child Safety
- Keywords
- Feeding practices, Diet, Physical activity, Prevention
- Medical subject headings
- Overweight, Obesity, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Physical Activity and NutritionBehavioural
At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.
ParentingBehavioural
Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.
Child SafetyBehavioural
The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Physical Activity and Nutrition | Experimental | A maternal intervention focusing on healthy diet and physical activity patterns for mothers. Receives: Behavioral: Maternal Physical Activity and Nutrition |
| Parenting | Experimental | A toddler parenting intervention focusing on parenting, limit setting, and development strategies. Receives: Behavioral: Parenting |
| Child Safety | Experimental | Attention control group. The parents received intervention to promote safety among toddlers. Receives: Behavioral: Child Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Body Mass Index (BMI) Z-score for Toddlers
Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.
Measured: Baseline to 12-month Follow-up
Change in Body Mass Index (BMI) Score Among Mothers
Change body mass index (BMI, kg/m^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.
Measured: Baseline to 12 month Follow-up
Secondary outcomes (5)
Change of Diet Quality for Toddlers
Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall. The range is 0-100, with higher scores representing better diet quality.
Measured: Baseline to 12-month Follow-up
Change of Diet Quality for Mothers
Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall. Scores range from 0-100, with higher scores optimal
Measured: Baseline to 12-month Follow-up
Change of Child Physical Activity
Physical activity is measured by wearing an accelerometer for 7 days. Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
Measured: Baseline to 12-month Follow-up
Change of Maternal Physical Activity
Physical activity is measured by wearing an accelerometer for 7 days. Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
Measured: Baseline-12 month follow up
Feeding Style
The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal. The maternal and child sub-scale scores were averaged for a total mealtime interaction score. The total score ranges from 1-7. Coders were trained until they demonstrated inter-rater reliability >0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator. Inter-rater reliability was reviewed through weekly reliability checks.
Measured: Baseline to 12 month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startApr 2006
- Primary completionSep 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Maureen Black, University of Maryland, Baltimore
- Investigators
- Maureen M Black, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615158
- Sponsor's protocol ID
- H-27980
- Other IDs
- R01HD056099, R03HD077156
- Acronym
- TOPS
- Status last verified
- May 2020
- First submitted
- 11 Feb 2013
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Campbell KL, Wang Y, Kuhn AP, Black MM, Hager ER. An ecological momentary assessment study of physical activity behaviors among mothers of toddlers from low-income households. BMC Womens Health. 2021 Mar 22;21(1):120. doi: 10.1186/s12905-021-01243-2.
PubMed 33752659Covington L, Armstrong B, Trude ACB, Black MM. Longitudinal Associations Among Diet Quality, Physical Activity and Sleep Onset Consistency With Body Mass Index z-Score Among Toddlers in Low-income Families. Ann Behav Med. 2021 Jun 28;55(7):653-664. doi: 10.1093/abm/kaaa100.
PubMed 33196078Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4.
PubMed 32885909Armstrong B, Covington LB, Hager ER, Black MM. Objective sleep and physical activity using 24-hour ankle-worn accelerometry among toddlers from low-income families. Sleep Health. 2019 Oct;5(5):459-465. doi: 10.1016/j.sleh.2019.04.005. Epub 2019 Jun 3.
PubMed 31171491Wang Y, Gielen AC, Magder LS, Hager ER, Black MM. A randomised safety promotion intervention trial among low-income families with toddlers. Inj Prev. 2018 Feb;24(1):41-47. doi: 10.1136/injuryprev-2016-042178. Epub 2017 Apr 6.
PubMed 28385953
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention
- ClinicalTrials.gov ID
- NCT02615158
- Acronym / sponsor ID
- TOPS / H-27980
- Conditions
- Overweight, Obesity, Depression
- Keywords
- Feeding practices, Diet, Physical activity, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2006
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.
Detailed description
Background:
Overweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching).
Overweight, defined as a BMI > 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% "at risk of overweight," defined as a BMI > 85th percentile (Ogden et al., 2006).
Dietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight.
Purpose of Study:
The investigators are collaborating with the Anne Arundel County, MD Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the University of Maryland's Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions.
The investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth.
In addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maternal Physical Activity and Nutrition | Experimental | Behavioral: Maternal Physical Activity and NutritionA maternal intervention focusing on healthy diet and physical activity patterns for mothers. |
| Parenting | Experimental | Behavioral: ParentingA toddler parenting intervention focusing on parenting, limit setting, and development strategies. |
| Child Safety | Experimental | Behavioral: Child SafetyAttention control group. The parents received intervention to promote safety among toddlers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 yrs old
- Has child between 12-32 months
- Child able to walk
- Birth weight of child at least 5lbs. 8oz.
Key exclusion criteria (2 listed)
- Mom cannot be pregnant
- No known congenital problems or disabilities
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 |
|---|---|---|
| Maternal Physical Activity and NutritionAt each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends. | Behavioural | Maternal Physical Activity and Nutrition |
| ParentingBehavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development. | Behavioural | Parenting |
| Child SafetyThe intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals. | Behavioural | Child Safety |
Primary outcome
Change of Body Mass Index (BMI) Z-score for Toddlers
Time frame: Baseline to 12-month Follow-up
Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score. The range of BMI z-score is usually between -5 and +5. BMI z-score lower than -1.645 is defined as underweight. The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.
Change in Body Mass Index (BMI) Score Among Mothers
Time frame: Baseline to 12 month Follow-up
Change body mass index (BMI, kg/m^2, calculated by measured weight and height) from baseline to 12-month follow-up. The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height. Scores above 25 are considered overweight and scores above 30 are considered obese.
5 secondary outcomes
Change of Diet Quality for Toddlers
Time frame: Baseline to 12-month Follow-up
Change of Diet Quality for Mothers
Time frame: Baseline to 12-month Follow-up
Change of Child Physical Activity
Time frame: Baseline to 12-month Follow-up
Change of Maternal Physical Activity
Time frame: Baseline-12 month follow up
Feeding Style
Time frame: Baseline to 12 month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Derived from this study: PubMed 33752659Campbell KL, Wang Y, Kuhn AP, Black MM, Hager ER. An ecological momentary assessment study of physical activity behaviors among mothers of toddlers from low-income households. BMC Womens Health. 2021 Mar 22;21(1):120. doi: 10.1186/s12905-021-01243-2.
- Derived from this study: PubMed 33196078Covington L, Armstrong B, Trude ACB, Black MM. Longitudinal Associations Among Diet Quality, Physical Activity and Sleep Onset Consistency With Body Mass Index z-Score Among Toddlers in Low-income Families. Ann Behav Med. 2021 Jun 28;55(7):653-664. doi: 10.1093/abm/kaaa100.
- Derived from this study: PubMed 32885909Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4.
- Derived from this study: PubMed 31171491Armstrong B, Covington LB, Hager ER, Black MM. Objective sleep and physical activity using 24-hour ankle-worn accelerometry among toddlers from low-income families. Sleep Health. 2019 Oct;5(5):459-465. doi: 10.1016/j.sleh.2019.04.005. Epub 2019 Jun 3.
- Derived from this study: PubMed 28385953Wang Y, Gielen AC, Magder LS, Hager ER, Black MM. A randomised safety promotion intervention trial among low-income families with toddlers. Inj Prev. 2018 Feb;24(1):41-47. doi: 10.1136/injuryprev-2016-042178. Epub 2017 Apr 6.
- Study WebsiteLink provided by the sponsor.
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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.
Maureen M Black, PhD principal investigator
University of Maryland, College Park
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Physical Activity and Nutrition, Parenting and Child Safety in people with Overweight and Obesity, run by University of Maryland, Baltimore at 2 sites in United States.
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 4 inclusion and 2 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Body Mass Index (BMI) Z-score for Toddlers (time frame: Baseline to 12-month Follow-up). The study lists 2 primary outcomes in all. 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 NCT02615158, which also lists 6 linked publications.
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 12 May 2020.