NCT02494674

Brief Summary

This is a 1-month study that will examine the use of podcasting and a wearable wrist-worn device to track calorie intake and promote weight loss. A podcast is a digital audio file that can be listened to on portable media players, like iPods, and personal computers. This study will run from July 14, 2015 to August 11, 2015. In this study, you will receive weight loss information delivered via twice weekly podcasts. You will also track each meal you eat by wearing a provided watch-like device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

July 6, 2015

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Weight (kg)

    Assessed with a digital scale accurate to 0.1 kg

    4 weeks

Secondary Outcomes (1)

  • Energy intake (kilocalories)

    4 weeks

Study Arms (1)

Bite Counter tracking

EXPERIMENTAL

Study participants will be asked to track their energy intake via a wearable device called the Bite Counter. Participants will attend weekly meetings to provide feedback on the Bite Counter.

Behavioral: Bite Counter tracking

Interventions

Participants will be asked to use the bite counter to track all meals and provide feedback on using the bite counter for dietary self-monitoring.

Bite Counter tracking

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • BMI between 25- 49.9 kg/m2
  • live in Columbia, South Carolina area
  • be able to attend all assessment visits
  • have access to the Internet, a computer, and a smartphone (iPhone, Android, etc.)
  • have MD consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues
  • be free of an eating disorder as screened by the Eating disorder Screen for Primary care. (If a participant has an eating disorder, they will be referred to their family physician)
  • no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
  • able to prepare all their own meals (i.e. not living on-campus)

You may not qualify if:

  • major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, or pregnancy
  • pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 7 months, or currently breastfeeding o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult her care provider and will be dropped from the weight loss study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brie Turner-McGrievy, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 10, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations