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Cell Phone Intervention in Young Adults

Cell Phone Intervention in Young Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01092364
Acronym
CITY
Enrollment
365
Registered
2010-03-24
Start date
2010-11-30
Completion date
2014-10-31
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Young adults

Brief summary

Weight gain accelerates during early adulthood, and leads to the health consequences of obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll middle-aged adults. This study tests the hypothesis that a weight loss intervention that builds on prior research evidence but is enhanced with technological innovations will lead to weight loss in a diverse group of overweight and obese adults aged 18-35 years. The technology intervention, using cell phone applications, will be compared to an advice only control group and to a group receiving a more traditional personal coaching intervention.

Detailed description

Trials in middle aged adults indicate that weight loss can be achieved and sustained with frequent contact over a long period of time, frequent self-monitoring, social support and motivational counseling. However, it is unclear whether this strategy would work in younger adults. Based on life stage, cultural context, environmental circumstances, and marketing pressures, behavioral intervention may need to be substantially modified to be effective in young adults. Even more adaptation will be required for intervention to be effective in young adults from racial/ethnic minority groups. The proposed intervention builds on prior evidence with innovations directed at increasing effectiveness in young adults. Using cell phones to deliver a weight control intervention in this age group has the potential to be engaging, enjoyable, practical, cost-effective, sustainable, and broadly disseminated. We propose a trial in which a highly innovative but more risky intervention based almost entirely on use of cell phone technology and a second more incremental innovation over traditional behavioral intervention are each compared to a usual care control group. We will recruit a diverse target population of overweight/obese, generally healthy young adults, comprising approximately 35% non-Latino Whites, 35% non-Latino Blacks, and 30% Latinos, to be randomized to: 1) Usual care control: Educational materials and information but no behavioral intervention; 2) Cell-phone intervention: similar education and knowledge as the control group, but thereafter a behavioral intervention will be delivered almost exclusively via cell phone, particularly using the self-monitoring and social networking features of this technology; 3) Personal contact with cell-phone enhancement: personal contact intervention enhanced by cell-phone for self-monitoring. The post-randomization intervention period will last 24 months. The primary outcome is change in weight 12 months post-randomization; an important secondary outcome is weight change at 24 months. The formative phase will focus largely on technology/intervention development. To assess maintenance of weight loss, after completion of the primary outcome assessment (24 months post-randomization), participants in the control group are followed observationally; those in the cell-phone and personal coaching interventions are re-randomized to either continue intervention or stop intervention with observational follow-up. All participants who agree to participate in this maintenance phase are followed for an additional 2-3 years with data collection every 6-12 months.

Interventions

Behavioral lifestyle intervention for weight loss, compared to advice-only control.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-35 years; * BMI \>=25; * Using a cellphone.

Exclusion criteria

* Diabetes mellitus; * Pregnant or nursing; * Use of weight loss medications, systemic steroids, antipsychotics, or diabetes medication; * Prior weight loss surgery; * Cardiovascular (CVD) event in past 6 months; * Current malignancy.

Design outcomes

Primary

MeasureTime frame
Change in Body WeightBaseline and 24 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Cell Phone Intervention
Behavioral lifestyle intervention for weight loss, delivered by cell phone. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
122
Personal Counseling Intervention
Behavioral lifestyle intervention for weight loss, delivered by personal counseling. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control.
120
Advice Only
Advice only control group.
123
Total365

Baseline characteristics

CharacteristicPersonal Counseling InterventionAdvice OnlyCell Phone InterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
120 Participants123 Participants122 Participants365 Participants
Age, Continuous29.4 years
STANDARD_DEVIATION 4.3
29.6 years
STANDARD_DEVIATION 4.3
29.2 years
STANDARD_DEVIATION 4.2
29.4 years
STANDARD_DEVIATION 4.3
BMI34.9 Kg/m^2
STANDARD_DEVIATION 7.5
35.1 Kg/m^2
STANDARD_DEVIATION 7.5
35.7 Kg/m^2
STANDARD_DEVIATION 8.2
35.2 Kg/m^2
STANDARD_DEVIATION 7.8
Dietary intake50.8 Scores on the HEI scale
STANDARD_DEVIATION 3.6
50.7 Scores on the HEI scale
STANDARD_DEVIATION 4.4
51.6 Scores on the HEI scale
STANDARD_DEVIATION 4.2
51.0 Scores on the HEI scale
STANDARD_DEVIATION 4.1
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants5 Participants9 Participants21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
113 Participants118 Participants113 Participants344 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Physical activity1009.3 kcal/week
STANDARD_DEVIATION 1346.4
865.9 kcal/week
STANDARD_DEVIATION 1133.9
756.0 kcal/week
STANDARD_DEVIATION 846.1
879.7 kcal/week
STANDARD_DEVIATION 1134.2
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants5 Participants5 Participants12 Participants
Race (NIH/OMB)
Black or African American
48 Participants42 Participants42 Participants132 Participants
Race (NIH/OMB)
More than one race
3 Participants3 Participants0 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants6 Participants10 Participants
Race (NIH/OMB)
White
65 Participants70 Participants68 Participants203 Participants
Region of Enrollment
United States
120 Participants123 Participants122 Participants365 Participants
Sex: Female, Male
Female
85 Participants85 Participants84 Participants254 Participants
Sex: Female, Male
Male
35 Participants38 Participants38 Participants111 Participants
Waist Circumference
Females
107.4 cm
STANDARD_DEVIATION 16.4
107.9 cm
STANDARD_DEVIATION 15.7
109.3 cm
STANDARD_DEVIATION 18.4
108.2 cm
STANDARD_DEVIATION 16.8
Waist Circumference
Males
111.5 cm
STANDARD_DEVIATION 16.4
109.8 cm
STANDARD_DEVIATION 14.6
113.8 cm
STANDARD_DEVIATION 17.9
111.7 cm
STANDARD_DEVIATION 16.3
Weight99.3 kg
STANDARD_DEVIATION 23.4
101.3 kg
STANDARD_DEVIATION 22.6
102.4 kg
STANDARD_DEVIATION 25.2
101.0 kg
STANDARD_DEVIATION 23.7

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1220 / 1200 / 123
other
Total, other adverse events
8 / 1224 / 1201 / 123
serious
Total, serious adverse events
4 / 1224 / 1205 / 123

Outcome results

Primary

Change in Body Weight

Time frame: Baseline and 24 months

Population: Intention to treat

ArmMeasureValue (MEAN)Dispersion
Cell Phone InterventionChange in Body Weight-0.99 kgStandard Deviation 6.2
Personal Counseling InterventionChange in Body Weight-2.6 kgStandard Deviation 6
Advice OnlyChange in Body Weight-1.7 kgStandard Deviation 8.3

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026