Overweight and ObesityNCT04697225
Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
A study testing weight loss strategies and weight loss coaching sessions and email support in people with Overweight and Obesity, run by Towson University at 1 site in United States.
Trial summary
The objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. This weight loss program supports weight loss among parents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- weight loss strategies and weight loss coaching sessions and email support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 30 Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent
- age ≥18
- English speaking
- completion of screening and baseline data collection
- BMI ≥ 25 and weight < 300lbs (weight limit due to scale limitations)
- willing to lose weight through physical activity, weight tracking and decreased caloric intake
Show all 17Show fewer
- willing to make changes at home to facilitate a healthy weight
- willing to complete 12 weekly weight loss video coaching sessions (20 minutes/session)
- willing to use Skype, FaceTime, Zoom, or WebEx for regular intervention contact
- Internet/ cellular plan that is sufficient for weekly program video conferencing
- willing to use the study scale with cellular technology to report weights at baseline, 12 weeks, and 24 weeks.
- willing to use the study scale with cellular technology at least weekly during the study (12 weeks)
- completion of screening and baseline data collection
- Child
- age 8-18
- has a disability
- assent is required if the child is capable and willing to have height and weight taken by the parent at baseline, 12 weeks, and 24 weeks.
Who cannot join
- parent or child: previously diagnosed eating disorder, or treatment for an eating disorder
- parent: currently pregnant or plan to get pregnant in the next 6 months
- parent: planned weight loss surgery or procedure in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. This weight loss program supports weight loss among parents. It is a first step towards a parent-only approach to promote healthier weight among children with a disability.
- Conditions
- Overweight and Obesity
- Being tested
- weight loss strategies, weight loss coaching sessions and email support
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight loss strategiesBehavioural
Participants will receive recommendations on how to increase physical activity, decrease caloric intake, monitor their weight, and track the related behaviors and progress.
weight loss coaching sessions and email supportBehavioural
Participants will receive weekly coaching sessions and tailored support emails.
| Study group | Role | What they receive |
|---|---|---|
| weight loss program | Experimental | Not described Receives: Behavioral: weight loss strategies; Behavioral: weight loss coaching sessions and email support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change among the parents at week 12
Examine weight change (12 week - baseline) in kilograms (kg) among the parents in the 12-week weight loss program.
Measured: baseline and 12 weeks
Secondary outcomes (3)
Adherence with the scheduled weekly coaching calls
Examine the parent's adherence with the weekly coaching sessions using descriptive statistics, including percent, of coaching sessions attended.
Measured: baseline to 12 weeks
Weight change among the parents at week 24
Examine weight change in kg (24 week - baseline) among the parents 12 weeks after the end of the weight loss program.
Measured: baseline and 24 weeks
Change in BMI z-score among the children
Examine changes (12 week - baseline and 24 week - baseline) in BMI-z score among the children.
Measured: baseline, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start4 Jan 2021
- Primary completion31 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Towson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald Jerome, PhD, Principal investigator, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697225
- Sponsor's protocol ID
- 1181
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
- ClinicalTrials.gov ID
- NCT04697225
- Acronym / sponsor ID
- 1181
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Towson UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Jan 2021 (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 objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. This weight loss program supports weight loss among parents. It is a first step towards a parent-only approach to promote healthier weight among children with a disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weight loss program | Experimental | Behavioral: weight loss strategies, Behavioral: weight loss coaching sessions and email support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Parent
- age ≥18
- English speaking
- completion of screening and baseline data collection
- BMI ≥ 25 and weight < 300lbs (weight limit due to scale limitations)
Key exclusion criteria (3 listed)
- parent or child: previously diagnosed eating disorder, or treatment for an eating disorder
- parent: currently pregnant or plan to get pregnant in the next 6 months
- parent: planned weight loss surgery or procedure in the next 6 months
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 |
|---|---|---|
| weight loss strategiesParticipants will receive recommendations on how to increase physical activity, decrease caloric intake, monitor their weight, and track the related behaviors and progress. | Behavioural | weight loss program |
| weight loss coaching sessions and email supportParticipants will receive weekly coaching sessions and tailored support emails. | Behavioural | weight loss program |
Primary outcome
Weight change among the parents at week 12
Time frame: baseline and 12 weeks
Examine weight change (12 week - baseline) in kilograms (kg) among the parents in the 12-week weight loss program.
3 secondary outcomes
Adherence with the scheduled weekly coaching calls
Time frame: baseline to 12 weeks
Weight change among the parents at week 24
Time frame: baseline and 24 weeks
Change in BMI z-score among the children
Time frame: baseline, 12, and 24 weeks
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 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Gerald Jerome, PhD principal investigator
Towson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight loss strategies and weight loss coaching sessions and email support in people with Overweight and Obesity, run by Towson University 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 17 inclusion and 3 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 21 Nov 2023. 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?
Weight change among the parents at week 12 (time frame: baseline and 12 weeks). 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 21 Nov 2023.