An interventional study of Simple and Standard in Overweight and Obesity, Overweight and Obesity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 2 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 144 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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Inclusion Criteria (parent):
Inclusion Criteria (child):
Exclusion Criteria (parent):
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.
Behavioral: Simple
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.
Behavioral: Standard
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.
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.
Percent weight loss: objective
Weight change from baseline to 6 months calculated as a percent from baseline weight.
Time frame: Baseline, 6 Months
Weight
Absolute weight change from baseline to 6 months.
Time frame: Baseline, 6 Months
Dietary tracking adherence
Number of days of complete dietary tracking summed over the 6-month study period.
Time frame: from Baseline to 6 Months
Parent diet
Change in parent daily caloric intake as measured by 24-hour dietary recall from baseline to 6 months.
Time frame: Baseline, 6 Months
Child diet
Change in child daily caloric intake as measured by 24-hour dietary recall from baseline to 6 months.
Time frame: Baseline, 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.
Time frame: Baseline, 3 Months, 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
Time frame: Baseline, 6 Months
Minutes of moderate-to-vigorous physical activity
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
Sedentary behavior
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
Physical food environment
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
Social food environment
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
Household food rules
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
Weight control self-efficacy
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
Self-efficacy for exercise
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
Self-regulation
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
Depressive symptoms
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
Stress
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
Plan to share: No
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University of North Carolina, Chapel Hill