Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)

The Effect of a Stepped-care Approach to Long-term Weight Loss

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00714168

Acronym

Step-Up

Enrollment

363

Registered

2008-07-14

Start date

2008-03-31

Completion date

2011-09-30

Last updated

2016-02-01

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

Conditions

Obesity

Keywords

Weight Loss, Weight Control

Brief summary

The number of overweight and obese adults in the United States is increasing at a rapid rate. A stepped-care weight loss program, which at key times increases the frequency of contact between an individual trying to lose weight and the program staff, may be beneficial for achieving long-term weight loss. This study will compare a standard behavioral weight loss program with a stepped-care weight loss program in their abilities to help people who are overweight or obese to lose weight.

Detailed description

Obesity can lead to many serious health conditions, including high blood pressure, diabetes, heart disease, and stroke. It is estimated that more than 65% of adults in the United States are overweight or obese, which is a significant increase over the past two to three decades. Although numerous studies have identified successful programs that help people achieve initial weight loss, few weight loss programs have shown promise for long-term success. Research has shown that a weight loss program in which there is continued contact between the program leader and the participant may improve long-term weight loss outcomes. In addition, a stepped-care approach to weight loss, in which contact between the participant and program leader increases when needed to achieve the next weight loss goal, may be beneficial. This study will examine whether a long-term weight loss program delivered in a stepped-care manner results in greater weight loss than does a standard behavioral weight loss program. Study researchers will also evaluate the cost effectiveness of both programs. Participants in this 18-month study will be randomly assigned to either a standard behavioral weight loss program or a stepped-care weight loss program. Participants in the standard behavioral weight loss program will attend group meetings once a week for Months 1 to 6, every other week for Months 7 to 12, and once a month for Months 13 to 18. The group meetings will focus on modifying eating habits and physical activity behaviors to improve weight loss. Participants in the stepped-care weight loss program will take part in a combination of treatments, whose timing and intensity will depend on the participants' abilities to achieve predetermined weight loss goals. These treatments may include attending monthly group meetings, receiving weekly weight loss information in the mail, receiving telephone calls from study staff to discuss weight loss behaviors, taking part in individual sessions with study staff to discuss weight loss, and receiving meal replacements (e.g., Slim Fast shakes, meal bars). Participants who do not achieve their weight loss goals at select time points during the study will receive more individual attention from study staff. All participants will follow a diet that focuses on decreasing calories and fat. They will be instructed to follow a walking program 5 days a week and to keep a food and exercise diary. Participants will also have access to a Web site that will include a study calendar and information about how to change eating and exercise behaviors; the use of this Web site is optional. Study visits will occur at baseline and Months 3, 6, 9, 12, 15, and 18. At each visit, participants' weight and height will be measured, and participants will complete questionnaires about their mood, general health, and exercise and diet habits. At baseline and Months 6, 12, and 18, participants will undergo measurements of blood pressure, fat, muscle, and waist and hip circumferences. Also at these times, physical fitness levels will be measured through a treadmill walking activity, during which an electrocardiogram (ECG) will record heart rate. For 7 consecutive days at baseline and Months 6, 12, and 18, participants will wear an activity monitor to measure physical activity levels.

Interventions

BEHAVIORALStandard Behavioral Weight Loss Program

This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.

BEHAVIORALStepped-Care Weight Loss Program

In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Body mass index (BMI) between 25.0 and 39.9 kg/m2

Exclusion criteria

* Reports losing more than 5% of current body weight in the 6 months before study entry * Participated in a research project involving weight loss or physical activity in the 6 months before study entry * Pregnant during the 6 months before study entry, currently breastfeeding, or planning to become pregnant in the 18 months after study entry * Current treatment for any medical condition that could affect body weight (e.g., diabetes mellitus, cancer) * History of heart attack or heart surgery, including bypass or angioplasty * Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers) * Currently taking medication that could affect metabolism or change body weight (e.g., synthroid) * Currently being treated for psychological issues or has taken psychotropic medications in the 6 months before study entry

Design outcomes

Primary

Measure	Time frame	Description
Weight Loss	Measured at Month 18	Change in Weight from Baseline

Secondary

Measure	Time frame	Description
Physical Activity	Measured at Month 18	Change in Physical Activity from Baseline
Energy Intake	Measured at Month 18	Change in Energy Intake from Baseline
Cardiovascular Fitness	Measured at Month 18	Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline
Body Composition	Measured at Month 18	Change in Percent Body Fat from Baseline

Countries

United States

Participant flow

Recruitment details

Recruitment included television and newspaper advertisements. Participants were enrolled between May 2008 and February 2010 at 2 clinical sites: 1) University of Pittsburgh, 2) University of North Carolina - Chapel Hill.

Pre-assignment details

433 individuals attended an orientation and provided written informed consent. Of these, 70 did not schedule a baseline assessment, failed to show for a baseline assessment, or were found to be ineligible after written consent was obtain. Thus, 363 were randomized to participate in this study.

Participants by arm

Arm	Count
Standard Behavioral Weight Loss Program Participants will take part in a standard behavioral weight loss program. Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.	165
Stepped-Care Weight Loss Program Participants will take part in a stepped-care weight loss program. Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.	198
Total	363

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	32	50
Overall Study	Non-study medical condition	3	2
Overall Study	Pregnancy	5	4
Overall Study	Relocation	4	3

Baseline characteristics

Characteristic	Total	Standard Behavioral Weight Loss Program	Stepped-Care Weight Loss Program
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	363 Participants	165 Participants	198 Participants
Age, Continuous	42.20 years STANDARD_DEVIATION 9.03	42.39 years STANDARD_DEVIATION 9.22	42.04 years STANDARD_DEVIATION 8.89
Region of Enrollment United States	363 participants	165 participants	198 participants
Sex: Female, Male Female	300 Participants	136 Participants	164 Participants
Sex: Female, Male Male	63 Participants	29 Participants	34 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 165	0 / 198
serious Total, serious adverse events	0 / 165	0 / 198