Trial Outcomes & Findings for mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology (NCT NCT00415870)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

4 months

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Control Enhanced Usual Care	PACE Received text messages and counseling calls Food Monitoring : Food Monitoring Text Message : Text Message Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device Diet Goals via Cell Phone : Diet Goals via Cell Phone Weekly Weighing : Weekly Weighing Printed Material : Printed Material
Overall Study STARTED	32	33
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control: Enhanced Usual Care n=32 Participants Enhanced usual care	PACE: Intervention - SMS Messages and Lifestyle Counseling n=33 Participants Received text messages and counseling calls	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42.4 years STANDARD_DEVIATION 7.5 • n=5 Participants	47.4 years STANDARD_DEVIATION 7.1 • n=7 Participants	44.9 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Control:Enhanced Usual Care n=32 Participants Enhanced Usual Care	PACE: Intervention - SMS Messages n=33 Participants Received text messages and counseling calls
Mean Weight (kg)	87.85 kg Standard Deviation 14.11	85.17 kg Standard Deviation 18.16

SECONDARY outcome

Timeframe: 4 months

Population: Participants in the control condition did not receive the program satisfaction survey. For those in the PACE-intervention arm, it was not mandatory to complete the program satisfaction survey and thus the number of participants who completed it are reflected in the data submitted.

Participants reported a 2 if they liked the program, 1 if they felt neutral about the program, and 0 if they did not like program. Higher scores reflect greater satisfaction.

Outcome measures

Outcome measures
Measure	Control:Enhanced Usual Care Enhanced Usual Care	PACE: Intervention - SMS Messages n=24 Participants Received text messages and counseling calls
Program Satisfaction	—	1.88 score on a scale Standard Deviation .44

SECONDARY outcome

Timeframe: 4 months

Population: We did not collect these data from the phone nor reported them in our main outcome paper. To the best of our recollection we shifted our emphasis from recording types of food and amounts of food to the behaviors of eating that were reflected in the Eating Behavior Inventory (O'Neill et al, 1979; citation #20 in the main outcome paper).

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PACE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Project Coordinator

UCSD

Phone: 858-534-9329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place