Feasibility Study of Receiving Feedback Messages Based on Self-monitored Dietary Intake

NCT02829632 | Completed

• 1 other identifier: PRO14110537
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: This randomized clinical pilot will test the feasibility of having individuals self-monitor for 12 weeks and based on what the participants record be given feedback messages. The investigator will use this information to refine the questions and data collection procedures for the larger study. Participants will be randomized into 3 groups

• self-monitoring only
• self-monitoring w/ feedback messages
• self-monitoring w/feedback messages and group sessions Feedback messages will be delivered up to 4 times per day using a different schedule. The group sessions will be held in the 2nd, 4th and 8th week of the 12-week study. All participants will be asked to complete questionnaires and 2 assessment visits at baseline and 12 weeks.

Conditions

Overweight; Obesity

Keywords

mobile technology; feedback message; self-monitoring

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Changes in weight: measured as Percent change in weight from baseline to 12 weeks

  12 weeks

Secondary Outcomes (2)

• Adherence to treatment protocol

  12 weeks

• Adherence to self-weighing protocol

  12 weeks

Study Arms (3)

Experimental: Group Sessions

EXPERIMENTAL

Participants will be asked to attend 3 group meetings over a 12 week period. Groups will meet for approximately 1 hour on weeks 2, 4 and 8. At each of the group meetings, the participant will be weighed and a group leader will present information on topics related to eating and exercise.

Behavioral: Group Sessions; Behavioral: Feedback; Behavioral: Self-monitoring

Active Comparator: Self-Monitoring

EXPERIMENTAL

Active Comparator: Self-monitoring Participants will record diet, activity and weight as described above in the participant's smartphone app to assist the participant in losing weight.

Behavioral: Self-monitoring

Experimental: Feedback

EXPERIMENTAL

Participants will be sent via the participant's smartphone between 1 and 4 feedback messages a day about whether the participant has been self monitoring, or the amount of calories, fat or sugar the participant has consumed.

Behavioral: Feedback; Behavioral: Self-monitoring

Interventions

Group Sessions BEHAVIORAL

Participants will receive a 3-session behavioral lifestyle program for a healthful lifestyle and weight loss.

Experimental: Group Sessions

Feedback BEHAVIORAL

Participants will receive up to 4 daily feedback messages based on progress in attaining target behavior. The feedback messages will be delivered on a variable ratio schedule and tailored to data in subjects' dietary recordings.

Experimental: Feedback; Experimental: Group Sessions

Self-monitoring BEHAVIORAL

Participants will receive an one-time how to self-monitor using the smartphone session.

Active Comparator: Self-Monitoring; Experimental: Feedback; Experimental: Group Sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• BMI between 27-43
• have an Android smartphone,
• has not used app for self-monitoring at least 4 days/week for the past 3 months
• can attend group meetings.

You may not qualify if:

• persons who plan to become pregnant
• have diabetes or a medical condition in which weight loss in contraindicated
• unable to walk for exercise
• on a weight loss drug
• had bariatric surgery
• plans to relocate within 3 months of recruitment
• currently in a weight loss program. -

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• 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.

  PMID: 38375882 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing and Epidemiology

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 12, 2016
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)