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Overweight and ObesityPATHNCT03973424

Mobile Methods for Reducing Obesity Risk in Parents and Children

A study testing Simple and Standard in people with Overweight and Obesity and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity. Read more about this study

Who is it for?
Ages 2 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity, Overweight, Obesity
What is being tested?
Simple and Standard
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
14 Aug 2019to 21 May 2020
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 2 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Currently age 21-55.
  • Body mass index (BMI) of 25-50 kg/m².
  • Have one child between the ages of 2-12.
  • Own an iPhone running at least iOS11 with a data and text messaging plan.
  • Have the ability to read, write, and speak English.
  • Currently age 2-12.

Who cannot join

  • Lost more than 10 pounds in the last 6 months.
  • Currently participating in another nutrition or weight loss program.
  • Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity.
  • Currently pregnant or breastfeeding, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
  • Planning to relocate in the next 8 months.
  • Will be out of town for 2 weeks or more in the next 8 months.
Show all 14Show fewer
  • Cannot attend two visits at the UNC Weight Research Program clinic.
  • Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the PAR-Q (Physical Activity Readiness Questionnaire).
  • Treatment of diabetes with insulin or oral medications that may cause hypoglycemia.
  • History of clinically diagnosed eating disorder.
  • Diagnosis of schizophrenia or bipolar disorder.
  • Hospitalization for a psychiatric diagnosis within the last year.
  • Report a past diagnosis of or current symptoms of alcohol or substance dependence.
  • Another member of the household (family member or roommate) is a participant or staff member in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Mobile Methods for Reducing Obesity Risk in Parents and Children: A Randomized Trial

The purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity.

Read the detailed description

This is a 6-month randomized controlled trial comparing the efficacy of two smartphone-based dietary and weight change interventions among 70 parent-child dyads with at least one child between the ages of 2 and 12 (70 adults and 70 children ages 2-12). One intervention group (Simple) will use a simplified, low-burden form of dietary tracking in the study smartphone application and the other group (Standard) will use standard calorie tracking. Components of both interventions include (1) setting personalized goals for weight, dietary intake, and daily activity (2) adaptive text message interventions based on behavior change techniques such as goal setting and in-the-moment progress feedback several times per week, (3) weekly tailored feedback updated in the study smartphone app, and (4) weekly lessons on the smartphone app. The primary objective is to promote weight loss in the parents, and the secondary objective is to determine if one or both interventions produce a ripple effect of parent dietary change onto dietary changes in the child.

Being tested
Simple, Standard
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimpleBehavioural

    Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, use a simplified form of tracking only high-calorie, high-fat foods in the study smartphone app, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.

  • StandardBehavioural

    Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, track calorie intake, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.

Study groups in NCT03973424
Study groupRoleWhat they receive
SimpleExperimentalThis arm uses a simplified form of dietary tracking that involves tracking only high-calorie, high-fat foods, in addition to the core behavioral smartphone-delivered intervention that consists of weighing, physical activity, goal setting, adaptive text messages, tailored weekly feedback, and lessons.
Receives: Behavioral: Simple
StandardExperimentalThis arm uses standard calorie tracking, in addition to the core behavioral smartphone-delivered intervention that consists of weighing, physical activity, goal setting, adaptive text messages, tailored weekly feedback, and lessons.
Receives: Behavioral: Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent weight loss: objective

    Weight change from baseline to 6 months calculated as a percent from baseline weight.

    Measured: Baseline, 6 Months

  2. Weight

    Absolute weight change from baseline to 6 months.

    Measured: Baseline, 6 Months

Secondary outcomes (5)

  1. Dietary tracking adherence

    Number of days of complete dietary tracking summed over the 6-month study period.

    Measured: from Baseline to 6 Months

  2. Parent diet

    Change in parent daily caloric intake as measured by 24-hour dietary recall from baseline to 6 months.

    Measured: Baseline, 6 Months

  3. Child diet

    Change in child daily caloric intake as measured by 24-hour dietary recall from baseline to 6 months.

    Measured: Baseline, 6 Months

  4. Percent weight loss: WiFi scale

    Weight change calculated as a percent from baseline weight (measured in kg), using official assessment weights taken from participants' study-provided WiFi-enabled weighing scale and transmitted via WiFi, from baseline to 3, and 6 months.

    Measured: Baseline, 3 Months, 6 Months

  5. Child BMI-percentile

    Change in child BMI-percentile using at-home measurements of child's weight (on parent WiFi-enabled scale) and height

    Measured: Baseline, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start14 Aug 2019
  3. Primary completion6 May 2020
  4. Study completion21 May 2020

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03973424
Sponsor's protocol ID
17-3027
Acronym
PATH
Status last verified
Jun 2020
First submitted
3 Jun 2019
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PubMed 38375882

Questions about this trial

What is this clinical trial studying?

A study testing Simple and Standard in people with Overweight and Obesity and Overweight, run by University of North Carolina, Chapel Hill 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 14 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 16 Jun 2020. 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?

Percent weight loss: objective (time frame: Baseline, 6 Months). 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 NCT03973424, 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 16 Jun 2020.

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