Promoting Healthy Weight With 'Stability Skills First'

Study Overview
=================
Brief Summary
-----------------
Losing weight has many health benefits for women such as reducing the risk of heart attacks, high blood pressure, diabetes, and cancer. However, women often struggle with maintaining the weight they have lost. This may be because they need to learn skills for maintaining weight, not just losing weight. When is the optimal time is to learn these maintenance skills? It may be better to lose weight first and then learn maintenance skills since people may feel good about the weight they have lost and be motivated to maintain. Alternatively, it may be better to learn maintenance skills first and then lose weight since they may experience how easy it is to use these maintenance skills and become confident they can maintain a weight loss in the future. Therefore, this study will examine whether learning these maintenance skills--before or after losing weight--helps women succeed at maintaining weight loss.

Detailed Description
-----------------
This randomized trial will test whether learning a novel set of 'stability skills' before losing weight improves long-term weight management (i.e., during a subsequent follow-up period once classes and staff contact have ended). Overweight/obese participants will be randomly assigned to one of two conditions (Maintenance First or Weight Loss First). In the Maintenance First condition, participants will learn stability skills during a novel 8-week maintenance program before participating in a standard 20-week behavioral weight-loss program. In the Weight Loss First condition (usual care/active comparator condition), participants will participate in a standard 20-week behavioral weight-loss program followed by a standard 8-week problem-solving skills maintenance program. Participants in both conditions will participate in identical standard 20-week behavioral weight-loss programs and be offered the same number of 90-minute weekly classes over the 6-month intervention period, (thus matching for time and attention from study-led health educators). Participants will be assessed at baseline and 6 months during the 6-month intervention period and at 12 and 18 months during the subsequent 12-month follow-up period (i.e., after classes and staff contact have ended). There will be no intervention staff contact during the 12-month follow-up, only 6, 12 and 18-month assessments. The primary aim will test whether participants in the Maintenance First condition gain less weight during the 12-month follow-up period (i.e., 6-18 months) than those in the Weight Loss First (active comparator) condition. Secondary questions of interest include examining psychometrics of lifestyle behavior questions (e.g., physical activity).

Official Title
-----------------
Promoting Healthy Weight With 'Stability Skills First' (Fresh Start Weight Loss Study)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Behavioral weight-loss/lifestyle interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: These criteria include: women of any ethnic background; age 21 years or older; BMI 27-40; non diabetic; not pregnant or not planning to become pregnant within the next year and a half; planning to remain in the area for the next year and a half; not following a special diet; not participating in any other research trial, not participating in another weight-loss program or weight or eating habits support group; able to participate in physical activity; free of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; stable blood pressure, cholesterol, thyroid and/or hormone medications for at least 3 months; not taking weight-loss medications, and successful and timely completion of the eligibility process. Exclusion Criteria: These criteria include: all men; women younger than 21 years of age; BMI outside of range 27-40; diabetic; pregnant or planning to become pregnant within the next year and a half; not planning to remain in the area for the next year and a half; following a special diet; participating in another research trial; participating in another weight-loss program or weight or eating habits support group; not able to participate in physical activity; has a history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; taking blood pressure, cholesterol, thyroid, and/or hormone medications for less than 3 months; taking weight-loss medications, or unsuccessful and/or untimely completion of the eligibility process.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance First<br> | Behavioral: Behavioral weight-loss/lifestyle interventions<br>* 6-month intervention (28 weekly classes)<br>|
| Active Comparator: Weight Loss First<br> | Behavioral: Behavioral weight-loss/lifestyle interventions<br>* 6-month intervention (28 weekly classes)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Body weight will be measured at baseline, 6, 12, and 18 months on a California state-certified standard beam balance scale at the research center with participants in light clothing and without shoes. | 12-month follow-up period (6-18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Physical activity will be assessed at baseline, 6, 12, and 18 months using the Stanford Leisure-Time Activity Categorical item (L-Cat). The L-Cat is self-administered and comprised of six ordered activity categories that range from inactive to very active. Participants pick the category that best describes their activity during the past month. | 6 months | 
| Pedometer steps | During the 6-month intervention sessions, participants will be asked to wear Omron dual axial pedometers (Model HJ-720ITC) every day during waking hours except when showering or swimming, and to record their steps per day and mean steps each week | 6 months |