Childhood ObesityNCT03661918
CHAT at HOME Pilot Study
A study testing In-Person First Session, Second Caregiver and WiFi-enabled Scale in people with Childhood Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- In-Person First Session, Second Caregiver and WiFi-enabled Scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 1 Sep 2019
- Phase
- Interventional
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent/primary caregiver of child in the 8-12 year old age range based on child birth date
- The child's BMI is greater than or equal to the 85th percentile according to CDC age and sex reference standards
- Child lives with parent/primary caregiver 50% of the time
- Willing to have a second caregiver participate in this study
- Wifi at home
- The parent and child can speak, read, and understand English
Who cannot join
- Kidney disease, Type 1 diabetes, Lupus, current Cancer diagnosis,
- Chromosomal abnormality such as Down's syndrome or Turner's syndrome
- Child taken any steroid medications such as Prednisone, Prenisilone and Decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids)
- Child enrolled in a different weight management program
- Family participating in any other child research study related to dietary intake, physical activity, weight
- Plans to move more than 50 miles from your present location within the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Changing Habits Together at Home Pilot Study
This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.
Read the detailed description
All participants in this study will receive 10 core coaching sessions. These sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the BMI scale. The sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's BMI. In addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins.
- Conditions
- Childhood Obesity
- Being tested
- In-Person First Session, Second Caregiver, WiFi-enabled Scale, 10 Core Coaching Calls Only
- Keywords
- Parent, adolescent, coaching, weight loss
- Medical subject headings
- Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person First SessionBehavioural
Conduct first session in person vs. over the phone
Second CaregiverBehavioural
Have second caregiver participate in three coaching calls
WiFi-enabled ScaleBehavioural
Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale
10 Core Coaching Calls OnlyBehavioural
Participant will receive 10 core phone coaching sessions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | In-person first session, no second caregiver, no wifi-enabled scale Receives: Behavioral: In-Person First Session |
| Group 2 | Other | In-person first session, no second caregiver, wifi-enabled scale Receives: Behavioral: In-Person First Session; Behavioral: WiFi-enabled Scale |
| Group 3 | Other | In-person first session, second caregiver, no wifi-enabled scale Receives: Behavioral: In-Person First Session; Behavioral: Second Caregiver |
| Group 4 | Other | In-person first session, second caregiver, wifi-enabled scale Receives: Behavioral: In-Person First Session; Behavioral: Second Caregiver; Behavioral: WiFi-enabled Scale |
| Group 5 | Other | No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only Receives: Behavioral: 10 Core Coaching Calls Only |
| Group 6 | Other | No in-person first session, no second caregiver, wifi-enabled scale Receives: Behavioral: WiFi-enabled Scale |
| Group 7 | Other | No in-person first session, second caregiver, no wifi-enabled scale Receives: Behavioral: Second Caregiver |
| Group 8 | Other | No in-person first session, second caregiver, wifi-enabled scale Receives: Behavioral: Second Caregiver; Behavioral: WiFi-enabled Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Data
Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.
Measured: 4 months
Secondary outcomes (1)
Child BMI
Track and measure child BMI percentiles at beginning and end of study.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start27 Nov 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is a 2 x 2 x 2 randomized clinical trial. In addition to the 10 core coaching sessions, there will be three additional components available to participants, depending on the experimental condition to which they are randomized. These potential additional components include 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Sherwood, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661918
- Sponsor's protocol ID
- STUDY00004193
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Habits Together at Home Pilot Study
- ClinicalTrials.gov ID
- NCT03661918
- Acronym / sponsor ID
- STUDY00004193
- Conditions
- Childhood Obesity
- Keywords
- Parent, adolescent, coaching, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 7 Sep 2018 (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.
This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.
Detailed description
All participants in this study will receive 10 core coaching sessions. These sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the BMI scale. The sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's BMI. In addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- This study is a 2 x 2 x 2 randomized clinical trial. In addition to the 10 core coaching sessions, there will be three additional components available to participants, depending on the experimental condition to which they are randomized. These potential additional components include 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Behavioral: In-Person First SessionIn-person first session, no second caregiver, no wifi-enabled scale |
| Group 2 | Other | Behavioral: In-Person First Session, Behavioral: WiFi-enabled ScaleIn-person first session, no second caregiver, wifi-enabled scale |
| Group 3 | Other | Behavioral: In-Person First Session, Behavioral: Second CaregiverIn-person first session, second caregiver, no wifi-enabled scale |
| Group 4 | Other | Behavioral: In-Person First Session, Behavioral: Second Caregiver, Behavioral: WiFi-enabled ScaleIn-person first session, second caregiver, wifi-enabled scale |
| Group 5 | Other | Behavioral: 10 Core Coaching Calls OnlyNo in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only |
| Group 6 | Other | Behavioral: WiFi-enabled ScaleNo in-person first session, no second caregiver, wifi-enabled scale |
| Group 7 | Other | Behavioral: Second CaregiverNo in-person first session, second caregiver, no wifi-enabled scale |
| Group 8 | Other | Behavioral: Second Caregiver, Behavioral: WiFi-enabled ScaleNo in-person first session, second caregiver, wifi-enabled scale |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Parent/primary caregiver of child in the 8-12 year old age range based on child birth date
- The child's BMI is greater than or equal to the 85th percentile according to CDC age and sex reference standards
- Child lives with parent/primary caregiver 50% of the time
- Willing to have a second caregiver participate in this study
- Wifi at home
Key exclusion criteria (6 listed)
- Kidney disease, Type 1 diabetes, Lupus, current Cancer diagnosis,
- Chromosomal abnormality such as Down's syndrome or Turner's syndrome
- Child taken any steroid medications such as Prednisone, Prenisilone and Decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids)
- Child enrolled in a different weight management program
- Family participating in any other child research study related to dietary intake, physical activity, weight
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 |
|---|---|---|
| In-Person First SessionConduct first session in person vs. over the phone | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| Second CaregiverHave second caregiver participate in three coaching calls | Behavioural | Group 3, Group 4, Group 7, Group 8 |
| WiFi-enabled ScaleHave participant weigh in weekly on a wifi-enabled scaled vs. regular scale | Behavioural | Group 2, Group 4, Group 6, Group 8 |
| 10 Core Coaching Calls OnlyParticipant will receive 10 core phone coaching sessions | Behavioural | Group 5 |
Primary outcome
Feasibility Data
Time frame: 4 months
Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.
1 secondary outcome
Child BMI
Time frame: 4 months
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 25 Sep 2019.
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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.
Nancy Sherwood, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person First Session, Second Caregiver and WiFi-enabled Scale in people with Childhood Obesity, run by University of Minnesota at 1 site 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 6 inclusion and 6 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Feasibility Data (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2019.