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Mobile Methods for Reducing Obesity Risk in Parents and Children (PATH)

Primary Purpose

Overweight and Obesity, Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Simple

Standard

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

2 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (parent):

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.

Inclusion Criteria (child):

Currently age 2-12.

Exclusion Criteria (parent):

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.
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.

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Simple

Standard

Arm Description

This 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.

This 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.

Outcomes

Primary Outcome Measures

Percent weight loss: objective

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

Weight

Absolute weight change from baseline to 6 months.

Secondary Outcome Measures

Dietary tracking adherence

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

Parent diet

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

Child diet

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

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.

Child BMI-percentile

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

Full Information

NCT ID

NCT03973424

First Posted

June 3, 2019

Last Updated

June 15, 2020

Sponsor

University of North Carolina, Chapel Hill

Collaborators

The Obesity Society

1. Study Identification

Unique Protocol Identification Number

NCT03973424

Brief Title

Mobile Methods for Reducing Obesity Risk in Parents and Children

Acronym

PATH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

August 14, 2019 (Actual)

Primary Completion Date

May 6, 2020 (Actual)

Study Completion Date

May 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

The Obesity Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simple

Arm Type

Experimental

Arm Description

Arm Title

Standard

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Simple

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent weight loss: objective

Description

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

Time Frame

Baseline, 6 Months

Title

Weight

Description

Absolute weight change from baseline to 6 months.

Time Frame

Baseline, 6 Months

Secondary Outcome Measure Information:

Title

Dietary tracking adherence

Description

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

Time Frame

from Baseline to 6 Months

Title

Parent diet

Description

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

Time Frame

Baseline, 6 Months

Title

Child diet

Description

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

Time Frame

Baseline, 6 Months

Title

Percent weight loss: WiFi scale

Description

Time Frame

Baseline, 3 Months, 6 Months

Title

Child BMI-percentile

Description

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

Time Frame

Baseline, 6 Months

Other Pre-specified Outcome Measures:

Title

Minutes of moderate-to-vigorous physical activity

Description

Change in minutes of moderate-to-vigorous physical activity as measured by the Paffenbarger Physical Activity Questionnaire, from baseline to 3, and 6 months. The PPAQ is a self-administered questionnaire that asks for a recall of physical activity over the previous 1 week. Participants report how many days and for how many minutes each day they engage in brisk walking, and report other exercise activities that week (non-occupational and non-household-related), including how many days and for how many minutes each time. Activities are assigned MET values according to the Compendium of Physical Activities, when are then used to classify activities as light moderate, or vigorous, and are also assigned energy expenditure amounts in kcal. These values are used to calculate total energy expenditure in kcal/week, as well as energy expenditure from and total minutes engaged in moderate-to-vigorous activities, measured in kcal/week and minutes/week, respectively.

Time Frame

Baseline, 3 Months, 6 Months

Title

Sedentary behavior

Description

Change in sedentary behavior as measured by the self-administered Sedentary Behavior Questionnaire for Adults (SBQ), from baseline to 3, and 6 months. The SBQ asks about amount of sitting time on weekdays (8 items) and weekends (8 items), and are scored by summing up the total time spent in sedentary time (in hours) on weekdays and weekends, ranging from 0 hours to 6+ hours per day.

Time Frame

Baseline, 3 Months, 6 Months

Title

Physical food environment

Description

Change in healthy and unhealthy foods offered in the home as measured by a physical food environment self-report questionnaire, from baseline to 3, and 6 months. There are 80 total items, 32 unhealthy items and 48 healthy items. Participants report whether each food/drink item is in the home or not (yes or no), and the items are summed for an unhealthy total and healthy total, and may also be used to total number of sugar-sweetened beverages/juice (out of 8 items), caloric beverages (15 items), fruits (17 items), vegetables (14 items), high-fat high-calorie items (20 items), and low-fat low-calorie items (14 items). Higher numbers indicate greater amounts of those types of food in the home.

Time Frame

Baseline, 3 Months, 6 Months

Title

Social food environment

Description

Change in social food environment as measured by the Meals in our Household Questionnaire, from baseline to 3, and 6 months. This consists of 50 items across 6 subscales, summed to create a total score for each: structure of family meals (10 items, score range 0-40), problematic child mealtime behaviors (20 items, range 0-70), use of food as a reward (6 items, range 0-24), parental concern about child's diet (17 items, range 0-85), spousal stress related to child's mealtime behaviors (4 items, score range 4-20), and influence of child's food preferences on what other family members eat (3 items, range 2-14). Higher scores indicate higher instances of use of the scale in question (ex: greater structure of family meals, greater use of food as a reward, etc.).

Time Frame

Baseline, 3 Months, 6 Months

Title

Household food rules

Description

Change in household food rules as measured by 12 items from the self-report Active Where Parent-Child Survey, from baseline to 3, and 6 months. The 12 items are summed to create a total score that ranges from 0-12, where higher scores indicate a greater number of food rules used.

Time Frame

Baseline, 3 Months, 6 Months

Title

Weight control self-efficacy

Description

Change in weight control self-efficacy using the 20-item self-report Weight Efficacy Lifestyle Questionnaire, from baseline to 3, and 6 months. Items are rated on a scale of 0-9, and summed for a total score ranging from 0-180, with higher scores indicated greater self-efficacy.

Time Frame

Baseline, 3 Months, 6 Months

Title

Self-efficacy for exercise

Description

Change in self-efficacy for exercise, as measured by the self-reported Self-Efficacy and Exercise Habits Survey, from baseline to 3, and 6 months. Responses for two subscales (Sticking to it - 8 items, Making time for exercise - 4 items) are averaged to yield a score from 1 to 5, with higher values representing higher self-efficacy for exercise.

Time Frame

Baseline, 3 Months, 6 Months

Title

Self-regulation

Description

Change in self-regulation as measured by the 26-item self-report Eating Behavior Inventory, from baseline to 3, and 6 months. Scores range from 26-130, with higher scores indicating more use of positive eating behaviors.

Time Frame

Baseline, 3 Months, 6 Months

Title

Depressive symptoms

Description

Change in depressive symptoms, as measured by the self-report 20-tem Center for Epidemiological Studies Depression Scale (CES-D), from baseline to 3, and 6 months. Scores range from 0-60, with higher scores indicating more depressive symptoms.

Time Frame

Baseline, 3 Months, 6 Months

Title

Stress

Description

Change in stress, as measured by the self-report 10-item Perceived Stress scale, from baseline to 3 and 6 months. Scores range from 0-40, with higher scores indicating greater stress.

Time Frame

Baseline, 3 Months, 6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (parent): 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. Inclusion Criteria (child): Currently age 2-12. Exclusion Criteria (parent): 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brooke Nezami, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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