Clinical trial

Optimization of Dietary Adherence in a Mobile Weight Loss Intervention

Opening soon · Not applicable · 1 countries · Registry ID NCT07582536

Opening soonNot applicableInterventional

What this study is about

The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often. The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach. The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight and/or Obesity

Full registry criteria

Inclusion Criteria: * BMI 25-50 kg/m2 at baseline * Own a smartphone with an active data and text messaging plan * English-speaking and writing * Willing to be randomized to any of the additional treatment components Exclusion Criteria: * Lost 5% or more of body weight (and kept it off) in the last 3 months * Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa) * Current symptoms of alcohol or substance dependence * Currently pregnant, pregnant within the past 6 months, currently breastfeeding, or planning to become pregnant within the next 6 months * Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months * Hospitalization for depression or other psychiatric disorders within the past 12 months * History of psychotic disorder or bipolar disorder * Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study * Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), except individuals on a stable dose of SSRIs for 3 months * Current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, PTH-analogues \[e.g., teriparatide, abaloparatide\], sclerostin inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years * Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4) * Report a health condition for which the program's dietary and physical activity recommendations would be unsafe, including hospitalization for heart failure, myocardial infarction or stroke in the past year, chronic kidney disease stage IV or V, liver failure or cirrhosis, chronic obstructive pulmonary disease on oxygen or requiring steroids, osteoporosis on medication, sarcopenia, history of fragility fractures, or dementia * Other health problems that may influence the ability to walk for physical activity or be associated with unintentional weight change, including current cancer diagnosis, cancer treatment within the past 5 years or tuberculosis * Previous surgical procedure for weight loss or planned weight loss surgery in the next year * Another member of the household is a participant or staff member on this trial * Ability to provide consent (4 items adapted from the UBACC \[University of California, San Diego Brief Assessment of Capacity to Consent\]) * Reason to suspect that the participant would not adhere to the study intervention * Does not live in the United States * Cannot have participated in a research study conducted by UNC Weight Research Program in the past 2 years Individuals endorsing joint problems, current treatment for hypertension or hyperlipidemia, or osteoporosis diagnosis not on medication will be required to obtain written physician consent to participate.

Treatments and study arms

Core

Behavioral

Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.

Switch to Simplified Diet Monitoring

Behavioral

Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.

Goal Autonomy/Planning

Behavioral

A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.

Just-in-time (JIT) Messaging

Behavioral

Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.

Coach Sessions

Behavioral

Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.

Primary outcomes

Total weeks of dietary goal adherenceTime of randomization to 6 months

Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met ≥ 3 days/week (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of North Carolina at Chapel Hill🇺🇸 Chapel Hill, North Carolina, United States
Karen E Hatley, MPHContact
Brooke T Nezami, PhDPrincipal Investigator